Comparison of Atypicals for First Episode Protocol 50771L/0114 _ SOURCE . DOCUMENT BINDER | Patient initials: [DIRIM| 0 Site/Patient number: | O Ulolololt L ‘Sponsored by Conducted by In coteboration wth Managed by Astrazeneca 2 ( ING. Duke University OQ Quames ‘AsiaZanaca Prarmecauicale LP or na Medical Center —aSCREENING VISIT CHECKLIST @ Date ofvisi: [24/03 Screening Demographics SCID/Interview SCID/Psychiatric History PMs History o Physical Examinatioy Clinical Global Impressions Abbreviated PANSS Baseline Eligibility Inclusion / Exclusion Criteria In Clinical Binder: Informed Consent Laboratory Measurements: © Liver Function Tests BUN Creatinine Chemistries CBC a CONFIDENTIAL 020009 &s Version 1.0 4/30/2002Patient initials: D/R M] visit dato (mm dd, yyy): [74 ‘SOURCE DOCUMENT THIS IS NOT A CRF 2412003 Site/Patient number: [0 [0 [1 ois Visi [ser] SCREENING DEMOGRAPHICS JMe Rater Initials: [7 Date of Birr AT 94 upafg 1/25 [bees 2 Sex Male Female a Race wnite | Black or African American ‘American Indian or Alas‘an Native Asian Native Hawaiian or Other Pacific Isiander 's patient Spanish/Hispanic/Latino? Yes No 5. Likely diagnosis CONFIDENTIAL ‘Schizophrenia, Disorganize type 295.10 ‘Schizophrenia, Paranoid type 296.30 | X ‘Schizophrenia, Undifferentiated type 295.90 ‘Schizophreniform Disorder 295.40 ‘Schizoaffective Disorder 295.70 0600: Cs Version 1.0 4/30/2002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: DY R/™ Visit date (mm da, yyy): [14 24 [208 ® Site/Patient number: | [0 [14 [0 [0 [o [4 ail Visit: [SCR SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS I DISORDERS CLINICIAN VERSION SCID4 Rater initials: _ SUK Michael B. First, M.D. Robert L. Spitzer, M.D. iam Gibbon, M.S.W. Janet B. W. Williams, D.S.W. Modified and used with the permission of the authors. The modules used include: Module A (Mood Episodes, modified to include the sections that cover Major Depressive, Manic, and Hypomanie Episodes, and Mood Disorder Due to a General Medical Condition or Substance Use). Module B-E, Module F Anxiety Disorders", including the complete SCID for OCD only, and screening questions and DSM IV Checks for other anxiety disorders). The E module was modified to have Substance Dependence Disorders screened first followed by Substance Abuse Disorders. The B module was modified by the adcition of 3 optional questions to item B5 to inquire for other delusions common in schizophrenic. & DSM-IV checklist is provided for Attention Deficit Disorder. Instructions: Complete the Demographics source document and items 23-28 from the SCIDIPsychiaiic History source document to collect basic demographic and treatment information forthe study subject Also, review the Medical History source document and Physical Exam source document to rule out Psychiatric disorder due to a general medical condition. Use the results of the SCID interview to score items 1-22 of the SCID/Psychiatric History source document. 000003 co Baer CONFIDENTIAL, Page 2 Version 1.0 5/8/2002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: DIR [M] Visit date (mm dd, yyy): [17 24 [2003 SitePatient number: [0 ]0 |1 [0 [0 fo Ti ]s Visit: [ SCR SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS I DISORDERS CLINICIAN VERSION SCID-I (continued) OVERVIEW OCCUPATIONAL HISTORY 7 What kind of work do you do? Are you working now? IF YES: How long have you worked there? (IF LESS THAN 6 MONTHS: Why did you leave your last job?) Have you always done that kind of work? IF NO: Why is that? What kind of work have you done before? How are you supporting yourself now? actor. Jeb intounism.in CA, Ve yrs. unhl wah eat Resigned aids —_ IF UNKNOWN: Has there ever been a period of time when you were unable to work or go to school? IF YES: When? Why was that? No CHIEF COMPLAINT AND DESCRIPTION OF PROBLEM 3 ‘What led to your coming here (this time)? (What is.the major problem you are having trouble with?) IF DOES NOT GIVE DETAILS OF PRESENTING PROBLEM: Tell me more about that. (What do you mean by...) -epunode Of ontremne stop cprived , tense diving Sduation — Q2weeks a no sleep, inhecurote Leli om S ONSET OF PRESENT ILLNESS OR EXACI -ERBATION 4 ‘When did this begin? (When did you first Notice that something was wrong?) When were you last feeling OK (Your usual saif? Peer ee NEW SYMPTOMS OR RECURRENCE {f this something new or a return of something you had before? (What made you come for help now?) CONFIDENTIAL Page 3 Ovoon, cs. Version 4.0 5/312 1002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: DIRIM] visita te (mm dd, yyy): | 17 24] 2003 Site/Patient number: [0 [0 ]1]0]0 10 [1 ]3 Visit: [SCR SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM4AV AXIS | DISORDERS CLINICIAN VERSION SCID-| (continued) Did anything happen or change just before this all started? {Do you think this had anything to do with your [PRESENT ILLNESS)? ‘What other kinds of problems were you having when this began? ENVIRONMENTAL CONTEXT AND POSSIBLE PRECIPITANTS 6 COURSE OF PRESENT ILLNESS OR EXACERBATION Lats oF Work, . Sarieo b made hyn yubrsr fh Yhase tumepts. Ko ofan 7 | Aterit started, what happened next? (Did ther things start to bother you?) 8 | Since this began, when have you fell the worst? IF MORE THAN A YEAR AGO: In the last year, when have you felt the worst? ee alates 18 day do — Phone anche plarmings OTHER CURRENT PROBLEMS a Have you had any other problems in the pastmonth? No 10 | What has your mood been like? Good Do you take any medications, herbal treatments, or vitamins (other than those you have already told me about)? IF YES: How much and how often do you take [MEDICATION]? (Has there been any change in the amount you have been taking?) is h [ ean een : PRNs ativan 12 | How much have you been drinking None [alcohol] {in the past month]? Have you been taking any drugs [in the ast month]? (What about marijuana, None ~cocaine, other street drugs?) ay ouooNs cs CONFIDENTIAL Page 4 Version 1.0 5/3/2002 dfSOURCE DOCUMENT THIS IS NOT A CRF Patient initials: DRM] visit date (mm dd, yyy): { 24 [2003 ® Site/Patient number: [0 [0 [7 [0 JO [0 ]7 [3 Visit: [ SCR SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID-I (continued) CURRENT SOCIAL FUNCTIONING P13 | How have you been spending yourfree | Reading, MOVIGA. time? Whom do you spend time with? tw 4 her bf, OVERVIEW DIAGNOSES [* MOST LIKELY CURRENT DIAGNOSES: | Sz, paranoid Ke P25 | DINGNOSES THAT NEED TO BE RULED =a : : ‘ e ‘OUT: Poycwosys Nos; Schizopltar, beedie es CONFIDENTIAL, Page 5 Version 1.0 5/3/2002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: p RJM] Visit date (mm dd, yyyy): [77 24 72003 Site/Patient number: [0 )0 [1 ]0 [0 [O77 [3 Visit: [ SCR SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID4 (continued) A. MOOD EPISODES: MAJOR DEPRESSIVE EPISODE CRITERIA FOR MAJOR DEPRESSIVE EPISODE: A. Five (or more) of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at least 1 of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure. ‘A | In the past month (1) depressed mood most of ‘has there been a period of time _| the day, nearly every day, as when you were feeling depressed _| indicated by either subjective ‘or down most of the day, nearly | report (e.g. feels sad or empty) ‘every day? (What was that like?) | Or observation made by others IF YES: How long did itast? (as _| (€-9: @Ppears tearful) long as 2 weeks?) A2 | ...what about losing interest or | (2) markedly diminished Pleasure in things you usually _| interest or pleasure in all, or enjoyed? almost al, activities most of IF YES: Was it nearly every day? | the day, nearly every day (as How iong did it ast? (as long as 2 | indicated by either subjective weeks?) account or observation made by others), “If neither At nor A2 is “Ves” during the current month, check for Major Depressive Episode In Ifatime by asking questions A1 and A2 again, beginning with “In your lifetime has there been... IF AT LEAST 1 PAST DEPRESSED PERIOD: In your lifetime have you had more than 1 time like that? ‘Which 1 was the worst? “if neither At nor A2 has been “Yes" in ifetime go to A16 (Manic Episode), OCooo4 CONFIDENTIAL Pageé Version 1.0 5/3/2002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: Site/Patient number: Visit date (mm dd, yyy 11 2a 2003 Oyo oy1 3 ‘SCR SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID-I (continued) FOR THE FOLLOWING QUESTIONS, FOCUS ON THE WORST 2-WEEK PERIOD: ‘A3__| During [2-week period}... (3) significant weight loss when not |? No Yes did you lose or gain any weight? (How | dieting or weight gain (e.g. a change much? Were you trying to lose weight?) am, than 8% of body weight in a month), or decrease or increase in IF NO; How was your appetite? (What : ‘about compared with your usual appetite: | 2PPetite nearly every day. Did you have to force yourself to eat? Eat {less/more] than usual? Was that nearly every day?) ‘Ad | ...how were you sleeping? (Trouble falling | (4) insomnia or hypersomnia nearly |? No Yes asleep, waking frequently, trouble staying | every day ‘sleep, waking too early, OR sleeping (00 much?’ How many hours a night compared with usual? Was that nearly every night?) AS | ...were you so fidgety or restless that you | (5) psychomotor agitation or 7 No Yes were unable to sit stil? (Was itso bad | retardation nearly every day that other people noticed it? What did __| (observable by others, not merely they notice? Was that nearly every day?) | subjective feelings of restlessness or being slowed down). IF NO: What about the opposite- talking ‘or moving more slowly than is normal for you? {Was it so bad that other people Toticed it? What did they notice? Was that nearly every day?) ‘A6 | ...what was your energy like? (Tired all__| (6) fatigue or oss of energy nearly |? No Yes the time? Nearly every day?) every day ‘AT | ...how did you feel about yourself? (7) feelings of worthlessness or 7 No Yes (Worthless? Nearly every day?) excessive or inappropriate guilt (which may be delusional) nearly IF NO: What about feeling guilty about ee er tena ot things you had done or not done? (Nearly | 2 7 every day?) NOTE: CODE "NO" IF ONLY LOW SELF-ESTEEM 000008 CONFIDENTIAL Page 7 Version 1.0 5/3/2002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: D TR [M] visit date (mm dd, yyy): [1 24 | 2003 Site/Patient number: [9 {0 [1 [0 [0 To [4 73 Visit: [ SCR SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSMAIV AXIS | DISORDERS CLINICIAN VERSION SCID-I (continued) "In your lifetime have tt symptoms that we've just talked about”? If*yes" go back to A1 and ask about that episode. ‘A | cid you have trouble thinking or (@) diminished abilty o think or 7 No Yes Concentrating? (What kinds of things didit | concentrate, or indecisiveness, nearly interfere with? Nearly every day?) ‘every day (elther by objective account or as observed by others) IF NO: Was it hard to make decisions about everyday things? ‘AS | _.were things so bad that you were (9) recurrent thoughts of death (not |? No Yes thinking @ fot about death or that you _| just fear of dying), recurrent suicidal Would be better off dead? What about _| ideation without specific plan, or a thinking of hurting yoursetf? suicide attempt or a specific plan for commiting suicide IF YES: Did you do anything to hurt yourself? Ato ‘A. ATLEAST 5 OF ITEMS A1-A9__|? No Yes | ‘ARE “Yes" AND AT LEAST 1 OF THESE ITEMS IS At OR A2. TFATO above is "No" (6, fewer than 6 are "Yes", ask the folowing F unknown: re been any other times when you've been depressed and had even more of the CONFIDENTIAL IF no" go to A16 (Manic Episode). Att | IF UNCLEAR: Has [the depression/OWN | C. The symptoms cause clinicaly |? No Yes WORDS] made it hard for you to do your | significant distress or impairment in yu work, take care of things at home, or get | social, occupational, or other Ate ‘along with other people? important areas of functioning. ‘A12_] Just before this began, were you D. The symptoms are not dus tothe |? No Yes physically il? Just before this began, _—| direct physiological effects of a y were you taking any medications? substance (e.g., a drug of abuse, “ate IF YES: Any change in the amount that _ | Medication) or a general medical you were taking? condition. ‘Just before this began, were you drinking L ‘or using any street drugs? | SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS Page oo00n9 es 1.0 6/3/2002SOURCE DOCUMENT THIS IS NOT A CRF e D TR |M] visit date (mm dd, yyy): [7 24 72003 Site/Patient number: [0 [0 ]1 [07070 ]1]3 Visit: | SCR CLINICIAN VERSION ‘SCID4 (continued) Etiological general medical conditions include degenerative neurological linesses (e.g. Parkinson's ‘disease, cerebrovascular disease (e.9 stroke), metabolic conditions (e.9. vitamin B12 deficiency), endocrine conditions (e.g. hyper- and hypothyroidism), viral or other infections (e.g, hepatitis), and certain Cancers (e.g. carcinoma of the pancreas). Etilogical substances include alcohol, amphetamines, Cocaine, hallucinogens, inhalants, opioids, phencyclidine, sedatives, hypnotics, anxiolytics, Medications include antinypertensives, oral contraceptives, corticosteroids, anabolic steroids, anticancer agents, analgesics, anticholinergics, cardiac medications. “IFA12 above is "No" (Le., mood is due to substance or general medical condition), ask the folowing Have there been any other times when you've been depressed and it was not because of (GENERAL ‘MEDICAL CONDITION/SUBSTANCE USE]? Iftyes" go back to At and ask about that episode. If*no" go to A16. — someone close to you died? accounted for by Bereavement, ie. | J after the loss [death] of a loved one, | aig the symptoms persist for longer than 2 months or are characterized by marked functional impairment, morbid preoccupation with worthlessness, suicidal ideation, Psychotic sympioms, or | psychomotor retardation. r ‘A13 || IF UNKNOWN: Did this begin soon after | E. The symptoms are not beller |? No Yes “ITA13 above is "No" (i, the depressed mood is better accounted for by Bereavement), ask the following: “Have there been any other times when you've been depressed and it was not because of a loss of a loved one? {*yes" go back to A1 and ask about that episode. I*no" go to A16 (Manic Episode). 002020 es E CONFIDENTIAL Page 9 Version 1.0 5/3/2002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: D [AM] Visitdate(mm ad, yyy): [ i | 24 [zoos SiteiPationt number: [0 | [( [o] 8] o| V] 4 visit: [sce | Rater initials [a [mf] SELECTED SECTIONS‘ OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID-I (continued) Ala GRITERIAA,C,D,ANDEARE | No Yes "Yes" (MAKE A DIAGNOSIS OF MAJOR z DEPRESSION.) IF UNKNOWN: Have you hiad (SYMPTOMS | MET CRITERIA FOR MAJOR No Yes RATED "Yes" ABOVE) in the past month? | DEPRESSION IN PAST MONTH | AS | How many separate times have you been | Total number of Major Depressive | [depressed/OWN WORDS| nearly every | Episodes, including surenn (CODE day for at least 2 weeks and had several of | 99 iftoo numerous or indistinct to | —— the symptoms that you just described, such | count) as [SYMPTOMS OF WORST EPISODE] | MANIC EPISODE ‘A16 | Have you ever had a period of ime when | A. A dlstincl period of abnormally es you were feeling so good, high, excited, or | and persistently elevated, hyper that other peoste thought you were | expansive, or iitable mood, Bt not your normal self or you got into trouble? (Did anyone say you were manic? Wes that more than just feling good?) What was that ike? IF NO: What about a period of time when you were so irritable that you found yourself shouting at people or starting fights or arguments? (Did you find yourself yelling at | peopie you didn't really know?) i ‘AIT | How long did that last? (As ong as 1 lasting at least 1 week (or any |? No Ves week? Did you have to go into the duration i hospitaization is v hospital?) necessary) 430 B. During the period of mood disturbance, 3 (er more) of the following symptoms have persisted (ifthe moed is only iitable) and Ouring [PERIOD OF WORST MANIC have been present to a significant SYMPTOMS], degree: Ovoo1t G CONFIDENTIAL Page 10 Version 1.0 5/8/2002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: DIR [TM] visit date (mm dd, yyyyy: [74 24 [2003 e Site/Patient number: [0 [0/1 [0 Jo [° 1 EF] Visit: | SCR SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID4 (continued) 18 | ...nhow did you feel about yourself? (1) inflated seit-esteem or 7 No Yes (More self-confident than usual? Any grandiosity special powers or ablities?) 19 | ...did you need less sleep than usual? (2) decreased need for sleep (e.g. |? No Yes IF YES: Did you still feel rested? ean after only 3 hours of ‘A20 | ..were you more talkative than usual? (Did | (3) more talkative than usualor |? NoYes People have trouble stopping you or Pressure to keep talking understanding you? Did people have {rouble getting a word in edgewise?) } | A2t | ...were your thoughts racing through your | (4) fight of ideas or subjective 2 No Yes e head? experience that thoughts are racing 22 | ...were you so easily distracted by things | (6) distraciiblity (ie, attention too |? No Yes around you that you had trouble easily drawn to unimportant or ‘concentrating or staying on 1 track? irrelevant external stimuli) ‘A23 | how did you spend your time? (Work, | (6) increase in goal-directed activity |? No Yes friends, hobbies? Were you so active that _ | (socially, at work or school-or your friends or family were concerned about | sexually) or psychomotor aattation you?) IF NO INCREASED ACTIVITY: Were you physically restless? (How bad was it?) ‘424 | ...did you do anything that could have (7) excessive involvement in 2 No Yes ‘caused trouble for you or your family? leasurable activities that have a (Buying things you didn't need? Anything | high potential for painful Sexual that was unusual for you? Reckless | consequences (e.g., engaging in ativing?) unrestrained buying sprees, sexual indiscretions, or foolish business _| investments) A25 ‘|B, ATLEAST 3 OF ITEMS 7 No Yes A18-A24 ARE “Yes” (OR 4 IF y MOOD IS IRRITABLE AND NOT “Bt ELEVATED) “if AB above is "No (Le, fewer than 3 are "Yes") ask the following: “Have there been any other times when you were (high/initable/OWN WORDS) and had even more of the symptoms that we've just talked about?” e It*yes,* go back to A16 and ask about that episode. Ouoe 2 ce CONFIDENTIAL Page 11 Version 1.0 5/3/2002SOURCE DOCUMENT THIS IS NOTA CRF Patient initials: DR [™] visit date (mm dd, yyy): [ 1 24 | 2003 Site/Patient number: [9 [0 [1 [0 [0 fo [4 [3 visit: | SCR if "no" go to BT (Psychotic and Associated Symptoms), SELECTED SECTIONS” OF THE STRUCTURED CLINICAL INTERVIEW FOR DSMAIV AXIS | DISORDERS CLINICIAN VERSION SCID-I (continued) IF NOT KNOWN; At that time, did you have serious problems at home or at work (school) because you were [SYMPTOMS] (did you have to go into a hospital? , ‘The mood disturbance Is sufficiently severe to cause marked impairment in occupational functioning or in usual social activities or relationships with others, ‘or to necessitate hospitalization to prevent harm to self or others, or there are psychotic features. 2 No* Yes: “IFA26 above is "No" (ce., not sufficiently severe) ask the following: Have there been any other times when you were [high/irrtable/OWN WORDS] and you got into trouble with people or were hospitalized? |F*yes,” go back to A16 and ask about that episode. If*no" go to A39 (Criterion C for Hypomanic Episode). ae A27 | Just before this began, were you physically ii? Just before this began, were you taking any medications? IF YES: Any change in . The symptoms are not due to the | ? No” Yes direct physiological effects of a substance (e.9., a drug of abuse, the amount that you were taking? Just before this began, were you di using any street drugs? medication) or a general medical condition’. “If A27 above is “No*(/e., the mania is due to a substance or general medical condition) ask the following: “Have there been any other times when you were [high/iritable(OWN WORDS] and you were not [physically ilvtaking medication/using SUBSTANCE]?” Iftyes," go back to A16 and ask about that episode If *no" go to A39 (Criterion C for Hypomanic Episode), ‘Note; Manic-like episodes that are clearly caused by somatic antidepressant treatment (e.g. medication, electroconvulsive therapy, light therapy) should not count toward a diagnosis of Bipolar | Disorder but are considered Substance-Induced Mood Disorders. Etiological general medical conditions include degenerative neurological ilinesses (e.g. Huntington's Disease, Multiple Sclerosis), cerebrovascular disease (e.g. stroke), metabolic conditions (e.g, vitamin B12 deficiency, Wilson's disease), endocrine conditions (.g., hyperthyroidism), viral or other infections, and certain cancers (e.g., cerebral neoplasms) Etiological substances include alcohol, amphetamines, cocaine, hallucinogens, inhalants, opioids, phencyclidine, sedatives, hypnotics, and anxiolytics. Medications include psychotropic medications (e.g antidepressants), antihypertensives, oral contraceptives, corticosteroids, anabolic steroids, isoniazid, antiparkinson medication (e.g. levodopa), and sympathomimetics/decongestants, guogl: cs Version 1.0 5/3/2002 CONFIDENTIAL Page 12 ’Patient initials; DIRTM) visita Site/Patient number 070 |4 [ojo fo yt ys SOURCE DOCUMENT THIS IS NOT A CRF late (mm dd, yyyy): | 14 24 | 2003 SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS I DISORDERS CLINICIAN VERSION SCID-I (continued) 28 | CRITERIAA, B,C, AND D ARE "Yes" No Yes (MAKE A DIAGNOSIS OF MANIC EPISODE) IF UNKNOWN ; Have you had ‘ARE MANIC SYMPTOMS No Yes [SYMPTOMS RATED "Yes" ABOVE] in the | PRESENT IN THE PAST MONTH? ast month? A29 | How many separate times were you Total number of Manic Episodes, [HIGH/OWN WORDS) and had [ACKNOWLEDGED MANIC SYMPTOMS] for atleast a week (or were hospitalized)? including current (CODE 98iftoo | GoTo B1 indistinct or numerous to count) HYPOMANIC EPISODE (Only inquire if suspect hypomania.) A30 | IF UNKNOWN: When you were ‘A. A distinct period of persistently |? No Yes (highliritable/OWN WORDS), did ittast for | elevated, expansive, of initable U atleast 4 days? mood, lasting throughout at least 4 Bt Have you had more than one time lke that’ | 43S, that is clearly different from the (Which time were you the most usual non depressed mood. [highvirrtable/OWN WORDS)?) FOR ITEMS A31-A37 FOCUS ON THE MOST EXTREME EPISODE 31 | ...how did you feel about yourself? (1) inflated selt-esteem or grandiosity |? No Yes (More self-confident than usual? Any Special powers or abilities?) A32 | ...did you need less sleep than usual? (2) decreased need for sleep (e.g, |? No Yes IF YES: did you feel rested? feels rested after only 3 hours of sleep) ‘A33 | ..were you much more talkative than (8) more talkative than usual or ? No Yes usual? (Did people have trouble stopping _| pressure to keep talking you or understanding you? Did people have trouble getting a word in edgewise?) ‘A34/ | ...were your. thoughts racing through your _| (4) fght of ideas or subjective 7 No Yes head? {experience that thoughts are racing A35 | ...were you so easily distracted by things around you that you had trouble easily drawn to unimportant or (6) distractibility (\e., attention too |? No Yes ‘concentrating or staying on one track? irrelevant external stimuli) CONFIDENTIAL Page 13, OuguIA es Version 4.0 5/3/2002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: DIR |M] visit date (mm dd, yyy): [17 24° | 2003 Site/Patient number: [9 [0 [1 [0 [0 [0 [4 3] visit: [SCR SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID-I (continued) ‘A36 | ...how did you spend your time? (Work, | (6) Increase in goal-directed activity |? No Yes friends, hobbies? Were you so active that _ | (either socially, at work or school, or your friends or family were concerned about | sexuelly) or psychomotor agitation you?) IF NO INCREASED ACTIVITY: Were you physically restless? (How bad was it) ‘AST | ...did you do anything that could have (7) excessive involvement in > No Yes ‘caused trouble for you or your family? pleasurable activities that have a (Buying things you didn't need? Anything | high potential for painful sexual that was unusual for you? Reckless | consequences (e.g., engaging in driving?) unrestrained buying sprees, sexual indiscretions, or foolish business investments) A38 B. AT LEAST 3 OF A(31)-A(37) 7 No Yes ARE “Yes" (OR 4 IF MOOD IS u IRRITABLE AND NOT ELEVATED) Bt IFA3® is "No" (ie., fewer than three are “Yes"), ask the following; Have there been any other times when you were [high/iritable/OWN WORDS] and had even more of the ‘symptoms that we've just talked about? I“yes", go back to A30 and ask about that episode. It*no" go to B1 (Psychotic Disorder). 'A39_| IF UNKNOWN Is this very different from the | C. The episode is associated with an |? No Yes way you usually are? (How were you | unequivocal change in functioning u different? At work? With friends? that is uncharacteristic of the person Bt when not symptomatic. [PASSING Tro chareclorIslicaly "hy DOMManIO) weak The Na Tf A39 is "No" (Le., characteristically "hypomanic’) ask the following, Have there been any other times when you were [highvirritable/OWN WORDS] and you were really different from the way you usually are? Ifyes" go back to A20 and ask about that episode, If'no" go to B1 (Psychotic Disorder) yuo cs CONFIDENTIAL, Page 14 Version 1.0 5/3/2002SOURCE DOCUMENT THIS IS NOT A CRE Patient initials: [AM] Visit date(mm dd, yyy: [ 4 [24 | oo ] SitefPatient number: [9/0 [1 [9/0 [0 [1] 3} Visit: [6C#- Rater initials STM_A SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID-I (continued) Ifyes" go back to A30 and ask about that episode. | Ado. | IF UNKNOWN: Did other people notice the | D. The disturbance in mcod andthe |? No Yes ‘change in you? (What did they say?) ‘change in functioning are observable | by others, Bt FAO "No" (ce., not observable by others). Have there been any other mes when you were {[highirrtable(OWN WORDS] and other people did notice the change in the way you were acting? If “no” go to B1 (Psychotic Disorder), ‘41. | IF UNKNOWN: At the time, did youhave | E, The episode is not severe enough | ? NO Yes serious problems at home or at work to cause marked impairment in 4 (school) because you were [SYMPTOMS] social or occupational functioning, or ARB or did you have to 90 into @ hospital tonecessitate hospitaization, and there are no psychotic features. | If A41 is *No* (.e., severe enough to cause marked impairment), go back to A26, code "Yes" for that item, and continue with A27. ‘AA2_| Just before this began, were you physically | F. The symptoms are not due to the |? .No Yes in? Just before this began, were you taking any medications? IF YES: Any change in the amount you were taking? Just before this began, were you drinking or Using any street drugs? is there is any indication that the hypomania may be secondary (i. 8 direct physiological consequence of general medical condition or substance). direct physiological effects of a b substance (Le., adrug of abuse, a | 44. medication) or @ general medical condition. CONFIDENTIAL Page 15 Ogou16 es Version 1.0 5/3/2002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: D [#[ WM] visit date (mm dd yyy: [ At [24 [yoo Site/Patient number: [D| 0] 1] 0] 0] Of 1/3 visit: Ecp— Rater initials ly [ale SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS. CLINICIAN VERSION SCID-I (continued) a3 CRITERIA A, B, C, D, E, AND F ARE “Yes (MAKE A DIAGNOSIS OF HYPOMANIC EPISODE) No Yes ‘A44 | How many separate times were you [high | Total number Hypomanic Episodes Jitrtable/OWN WORDS] and had {CODE 89 if too indistinct or IACKNOWLEDEMENT HYPOMANIC. ‘numerous to count) SYMPTOMS] for a period of time? INQUIRE IF SUSPECT THIS DIAGNOSIS) MOOD DISORDER DUE TO A GENERAL MEDICAL CONDITION OR SUBSTANCE USE (ONLY ‘45 | A. A prominent and persistent disturbance in mood predominant in the clinical picture and by either (oF both) of the following: (1) depressed mood or markedly diminished interest or pleasure in all, or almost all, activities (2) elevated, expansive, of irritable mood ? No Yes ‘A46 |B. Either: There is evidence from the history, physical examination, or laboratory findings that the disturbance is the direct physiological consequence of a general medical condition, or There is evidence from the history, physical examination, or laboratory findings of either (1) or 2) (1) the symptoms in criterion A developed during, or within a month of, substance intoxication or withdrawal (2) medication use is etologically related to the disturbance. ? No Yes ‘A47_| D. The disturbance is not better accounted for by another mental disorder, 2_No Yes ‘AaB | E. The symptoms cause clinically significant distress or impairment in social, ‘occupational, or other important areas of functioning. ‘A4g_| CRITERIA A, B, C, AND E ARE “YES” (MAKE A DIAGNOSIS OF MOOD DISORDER DUE TO A GENERAL MEDICAL CONDITION OR SUBSTANCE USE) (This diagnosis is not scored on-SCID/Psychiatric History source document.) 2 No Yes No Yes Ousur: CONFIDENTIAL Page 16 Version 4.0 5/3/2002SOURCE DOCUMENT THIS IS NOT A CRF nt initials: D |t- [1] visitaate imm ad, yyy: [1 [24-00% | SiterPatient number: [0 | 0 | 1] 010 [0] EA Visit: [GUL Rater initials SS Im] et SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID-I (continued) B. PSYCHOTIC AND ASSOCIATED SYMPTOMS. DELUSIONS: False personal beliefs based on incorrect inference about external reality and firmly sustained in spite of what almost everyone else believes and in spite of what constitutes incontrovertible ‘and obvious proof or evidence to the contrary. The belief is not one ordinarily accepted by other members of the person's culture or subculture. Do not consider as delusions unreasonable and sustained beliefs that are maintained with less than delusional intensity ("overvalued ideas" B1 | Now! am going to ask you about unusual | Delusion of reference: ie., events, |? Ne ‘experiences that people sometimes have. | objects, or other people in the Has it ever seemed like people were talking | individual's environment have a ‘about you or taking special notice of you? particular or unusual significance (Has it ever seemed as if someone on the _| thats clearly unwarranted, radio, TV, or newspaper is sending you a special message?) 82 _| What about anyone going out of his orher | Persecutory delusion. ie., the No) Yes way to give you a hard time, or trying to hurt | individual (or his or her group) is you? being attacked, cheated, persecuted, ‘of conspired against, 83 | Did you ever feel that you were especially | Grandiose delusion; ie., content |? NA Yes, important in some way, or that you had involves exaggerated power, special powers to do things that other knowledge, or importance, or a people couldn't do? special relationship to a deity or (Do you have a special relationship with _| famous person. someone who is famous? Do you have @ special relationship with God?) B4 | Did you ever feel that something was very | Somatic delusion: ie., content ¢ NoYes wrong with you physically even though your | involves change or disturbance in doctor said nothing was wrong...like you | body appearance of functioning. had cancer or some terrible disease? Have you ever been convinced that something was very wrong with the way @ part or parts of you body looked? (Did you ever feel that something strange was happening to parts of your body?) SELECTED SECTIONS* OF THE §vis eAUo 18 STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORD! CONFIDENTIAL Page 17 Version 1.0 5/3/2002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: ole | isit date (mm dd, yyy): Le ve | ay [2004 SiteiPatient number: [o [0 | ( Lo] o[ 0] 1] 3] Visit: [Sof Rater initials 3] m ¢ CLINICIAN VERSION SCID-I (continued) 85 (Did you ever have any unusual religious. Other delusions; i.e., religious, td Yes HALLI experiences?) Did you ever fee! that {...you had committed a crime or done something terrible for which you should be punished?) (..-someone or something outside yourself was controlling your thoughts or actions ‘against your will?) (...someone could read your mind? ‘could read someone else's mind?) (...certain thoughts that were not your own were put into your head? What about taken out of your head? How about that your thoughts were broadcast out loud so that other people could hear them?) (Po you have any other beliefs that most people would consider unusual?) jealous, erotomanc, delusions of ‘guilt, delusions of being controlled, thought broadcasting, thought insertion, thought withdrawal (Check here if delusions are bizarre, ie. that involve a phenomenon that the person's culture would regard as totally implausible.) UCINATIONS: A sensory perception that has the compelling sense of reality of a true perception but gccurs without external stimulation or the relevant sensory organ 86 | Did you hear things that ather people Auditory halucinations when fully No res | couldn't hear, such as noises, or the volees_| awake, heard elther inside or outside of people whispering or taking. the head IF YES: What dd you hear? How often did_| (Check i voices give a running you hear it? ‘commentary on patient's thoughts ‘and behavior") a 87 | Did you ever have visions or see things that | Visual hallucinations ~[aGeyrer other people couldn't see? (Were you awake at the time?) 88 | What about strange sensations in your body | Tactile hallucinations. @9. a 3 Yes ‘ron your skin? aleotriiy 59 | What sbout smelling or tasting things that other people couldn't smell or taste? Other hallucinations, e g., gustatory, Yes olfactory. CONFIDENTIAL, Page 18 agecs4 cs Version 1.0 5/3/2002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: DR im Visit date (mm dd, yyyy): | 11 | 24 | 2003 | Site/Patient number: | 9 | 9 | Lo] o | O/t I, | Visit: | sce Rater initials. simi 4 SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM4V AXIS | DISORDERS CLINICIAN VERSION SCID-I (continued) THE REMAINDER OF THE ITEMS IN THIS SECTION ARE OBSERVATIONAL OR BY HISTORY Let me stop for a minute while | make a few notes 810 | Catatonia; e.g. catalepsy, stupor, catatonic agitation, negativism, mutism, 7 No Yes posturing, stereotyped movements, echolalia (senseless repeating or echoing the words of another), echopraxia (senseless, uncontrolled imitation of the movements of others) B11. | Grossiy disorganized behavior, 9., markedly disheveled appearance, grossly ? No Yes inappropriate sexual behavior, unpredictable or untiggered agitation 812 | Grossiy inapprooriate affect €.g., smil iscussing being persecuted No Yes B13 | Disoraanized speech. e.g., frequent derailment (loosening of associations) or 7 No Yes incoherence. B14 | Negative symptoms; je., affective flattening, alogia (poverty of thought, as indicated |? No Yes by poverty in content or production of speech). avoliion (inability to initiate or sustain goal directed activities) CHRONOLOGY OF PSYCHOTIC SYMPTOMS, If any delusions or hallucinations, note type, course, dnset and offset dates, and whether present during past month (e.,, "bizarre delusions of being controlled by aliens, present intermittently, onset 1962, offeet June 1983") Type of symptoms Course Onset Offset Present during past month? 0u0020 Cs CONFIDENTIAL Page 19 Version 1.0 5/3/2002Patient initials: DR IM] Visitdate(mmad, yyy: {1 [24 [20s . 9 Rater initials ky SOURCE DOCUMENT THIS IS NOT A CRF ] ruled out because either: (1) no Major Depressive, Manic, or Mixed Episodes have occurred concurrently with the active-phase symptoms (i, the “A” symptoms listed in C2). The following question may be asked for clarification: Has there ever been a time when you had [PSYCHOTIC SYMPTOMS] at the same time that you were depressed/highvirritable/OWN WORDS]? (@) If mood episodes have occurred concurrently during active-phase symptoms, their total duration has been brief relative to the duration of the active and residual periods ‘Question for clarification: How much ofthe time thet you have had [SYMPTOMS FROM ACTIVE AND RESIDUAL PHASES] would you say you have also been depressed/highiirtabie/OWN WORDS?” NOTE: Answer "yes" if 1. ...there have never been any Major Depressive, Manic, or Mixed Episodes, 2. fall such episodes occurred during the prodromal or residual phase, 3. ...or'f episodes everlap with psychotic symptoms AND the mood symptoms are NOT a significant part of the total disturbance, . Continuous signs of the disturbance persist for at least § MONTHS, This 6-month period must include at least 1 month of symptoms (or less if successfully treated that meet criterion A (\e., active-phase symptoms) and may include periods of ‘prodromal or residual symptoms. During these prodromal or residual periods, the signs of the disturbance may be manifested by only negative symptoms (i.e., affective flattening, alogia, avolition) or two or more symptoms listed in criterion A, present in an attenuated form (e.g. odd beliefs, unusual perceptual experiences). Question for clarification: Between [MULTIPLE EPISODES}, were you back to your normal self? How long did each episode last? u cn C5 8, For a significant portion of the time since the onset of the disturbance, one or more major areas of functioning such as work, interpersonal relations, or self-care are markedly below the level achieved prior to the onset (or when the onset is in childhood, of adolescence, failure to achieve expected level of interpersonal, ‘acacemic, or occupational achievement) E. The disturbance is not due to the direct physiological effects of a substance" (@g.,a drug abuse, @ medication) or general medical condition: ‘Questions for clanfication: Were you taking any drugs or medicines during this time? Were you physically il at this time? No (Yes u cat eee 4 "car CONFIDENTIAL Page 21 Version 0u0022 es 1.0 5132002SOURCE DOCUMENT THIS IS NOT A CRF D Te [m] visit date (mm ad, yyy): [11] ey feos ] tlololo Uz | Visit: [See ials Is Tm] 4 Site/Patient number: ° ° Rater SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID-i (continued) 7If CB "No* (ie., psychotic symptoms likely due to the direct effects of a substance or medical condition), {90 back to C2 and determine whether there are psychotic symptoms that are not due to a substance or general medical condition. Otherwise, go to C27. “Etiological general medical conditions include neurological conditions (e.g. neoplasms, cerebrovascular disease, Huntington's Disease, epilepsy, auditory nerve injury, deafness, migraine, central nervous system infections), endocrine conditions (e.g., hyper-and hypothyroidism. hyper-or hypoparathyroidism, hypocortsolism), metabolic conditions, (&.¢., hypoxia, hypercarbia, hypoglycemia), fluid or electrolyte imbalances, hepatic or renal diseases, and autoimmune disorders with central nervous involvement (e.9., systemic lupus erythematosis). Etiological substance include alcohol, amphetamine, cannabis, cocaine, hallucinogens, inhalants, opioids (meperidine), phencyclidine, sedatives, hypnotics, anxiolytics, and other or unknown substances, C7 | CRITERIA A,B,C.D, AND E ARE MET: PATIENT MEETS DIAGNOSTIC CRITERIA FOR SCHIZOPHRENIA, AND THUS MEETS DIAGNOSTIC.CRITERIA FOR THE TRIAL. p13. (Score on SCID/Psychiatric History source document.) SCHIZOPHRENIFORM DISORDER CRITERIA 8 | A. Criteria A for schizophrenia (C2 and C3 above) are met. No Yes u 22 C9] A. An episode of the disorder (including prodromal, active, residual phase) lasts at | No Yes least 1 month but less than 6 months. u Question for clarification: How iong did [PSYCHOTIC SYMPTOMS] last? C22 C10 | B. The disturbance is not due to the direct physiological effects of a substance | No Yes (e.g,, @ drug abuse, a medication) or a general medical condition, yoy Questions for clarification: Were you taking any drugs or medicines during this | C27 D123 time? Were you physically ill at this time? Refer to list of general medical conditions and substances in item C6. (IF YES: MAKE A DIAGNOSIS OF SCHIZOPHRENIFORM DISORDER), PATIENT MEETS DIAGNOSTIC CRITERIA FOR SCHIZOPHRENIFORM DISORDER, AND THUS MEETS DIAGNOSTIC CRITERIA FOR THE TRIAL. _{Score on SCID/Psychiatric History source document.) OudUL3 cs CONFIDENTIAL Page 22 Version 1.0 5'3/2002Patient initials: Di elm] Visitdate(mmad, yyy: 1 [gy |zvos SitePatient number: [©] 6] 1 ]o/o [oli [3] Visit: [Se Rater initials lata] 4 SOURCE DOCUMENT THIS IS NOT A CRF SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM4V AXIS | DISORDERS CLINICIAN VERSION SCID-I (continued) SCHIZOAFFECTIVE DISORDER CRITERIA C11 | A. Anuninterrupted period of ines during which, at some time, there is eithera | No” Yes Major Depressive Episode (which must include A(1) (depressed mood), a Manic, | or a Mixed Episode concurrent with symptoms that meet criterion A for 31 schizophrenia. C12 | B. During the same period of illness, there have been delusions or hallucinatons | No Yes for at least 2 weeks in the absence of prominent mood symptoms vu Question for clarification: Have there been any times when you had cat [PSYCHOTIC SYMPTOMS] when you were not [MANIC OR DEPRESSED]? 613 | C. Symptoms that meet criteria for a mood episode are present fora substantial | No Yes portion of the duration ofthe active and residual periods of the iliness y 31 C14 | D. The disturbance is not due to the direct physiological effects of a substance No Yes (eg.,a drug of abuse, a medication) or a general medial condition, NOTE: Refer | J. to list of general medical questions and substances in items C6. car Questions for clarification: Were you taking any drugs or medicines during this time? Were you physically il at this time? C15 | CRITERIA A, B, C, AND D ARE MET Yes (MAKE A DIAGNOSIS OF SCHIZOAFFECTIVE DISORDER). u PATIENT MEETS DIAGNOSTIC CRITERIA FOR SCHIZOAFFECTIVE, AND ide ‘THUS MEETS DIAGNOSTIC CRITERIA FOR THE TRIAL. (Score on SCID/Psychiatric History source document) EXCLUSIONARY DIAGNOSES DELUSIONAL DISORDER C16" | A. Nonbizzare delusions (i.e., involving situations that occur in reallife, suchas | No Yes being followed, poisoned, infected, loved at a distance, or deceived by a spouse | oF lover, or having a disease) of at least 1 month's duration c27 17 | B. Criterion A for Schizophrenia has never been met. NOTE: Tactile and No Yes olfactory hallucinations may be present in Delusional Disorder if they are | related to the delusional them c3t Dusuz+ os CONFIDENTIAL Page 23 Version 1.0 5/3/2002SOURCE DOCUMENT THIS IS NOT A CRF geo ec T : Patient initials: [D|2\M|} Visit date (mm dd, yyy): [11 Fry | eos | Site/Patient number: [oO] 0] [| O[o| 113 Visit: Ee} Rater initials lo fm] 4} C18 | C. Apart from the impact of the delusion(s) or its ramifications, functioning is not No Yes ‘markedly impaired and behavior is not ebviously odd or bizarre. u C31 ‘SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID- (continued) C19 |D. If mood episodes have occurred concurrently with delusions, their total duration | No Yeo has been brief relative to the duration of the delusional periods. u Questions for clarification: Has there ever been a time when you have believed cB [DELUSIONS] at the same time you were [depressed/highvirritable/OWN WORDS]? How much of the time that you have believed [DELUSIONS]. Would you Say you have also been [depressed/high/irritable/OWN. WORDS]? NOTE: Answer “yes” if 1) there have never been any mood episodes at all, 2) mood episodes occurred at times other than during delusional periods, or 3) mood episodes were brief relative to total duration of the delusional periods. Answer “no” ‘if symptoms meeting criteria for mood episodes have been present fora substantial portion of the total duration of the disturbance. C20 | E. The disturbance is not due to the direct physiological effects of a substance] No Yes (@.g., a drug of abuse, a medication) or a general medical condition. NOTE: u Refer to ist of general medical conditions and substances in item C6, page 31. | C27 ‘Questions for clarification: Were you taking any drugs or medicines during this time? Were you physically ill at the time? C21 | CRITERIA A, B, C, AND E ARE MET (MAKE DIAGNOSIS OF DELUSIONAL ‘Yes DISORDER). t Excluded END SCID BRIEF PSYCHOTIC DISORDER C22 | A. Presence of one (or more) of the following symptoms: No Yes (1) Delusions u (2) Hallucinations os (3) Disorganized speech (€.g., frequent derailment or incoherence) (4) Grossly disorganized or catatonic behavior Ouuued es CONFIDENTIAL Page 24 Version 1.0 5/3/2002P: SOURCE DOCUMENT THIS IS NOT A CRF nt initials: Le [elma] visit date (mm aa, yyy): [17 [ZH 2005 | iterPatient number: [> |a | { [O[O| Ol! | 2 Visit: [6A Rater initials S| mM) EE B. Duration of an episode of the disturbance is at least 1 day but less than 1 ‘month, with an eventual full return to premorbid level of functioning, No Yes y 31 SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS I DISORDERS CLINICIAN VERSION SCID4I (continued) C24 | C (1) The disturbance is not better accounted for by a Mood Disorder With No Yes Psychotic Features (see D1), Schizoaffective Disorder (see C1), or Schizophrenia | (see C2). ot cis C2 C25 | C (2) The disturbance is not due to the direct physiological effects ofa substance | No Yes (e.g., a drug of abuse, a medication) or the direct physiological consequence ofa | J) general medicai condition. NOTE: Refer to lst of general medical conditions and. | C27 Substances in item C6. Questions for clarification: Were you talking any drugs or medicines during this time? Were you physically il at this time? C26 | CRITERIA A, B, AND C ARE MET ita {MAKE A DIAGNOSIS OF BRIEF PSYCHOTIC DISORDER), Bewa END SCID PSYCHOTIC DISORDER DUE TO A GENERAL MEDICAL CONDITION OR SUBSTANCE USE C27 | A. Prominent hallucinations or delusions. No Yes (CODE BASED ON INFORMATION ALREADY OBTAINED} of 626 | B(1). Theres evidence from the history, physical examination, or laboratory No Yes findings that the disturbance is the direct physiological consequence of a general medical condition, and the disturbance is not better accounted for by another mental disorder. €29 | 8 (2). There is evidence from the history, physical examination, or laboratory No Yes findings of either. y 1. the symptoms in criterion A developed during, or within month of, cat Substance intoxication or Withdrawal, or 2. medication use is etiologically related to the disturbance. OvbUL6 “ CONFIDENTIAL Page 25 Version 1.0 5/3/2002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: ip;elm Visit date (mm dd, yyy): { [24 0a | Site/Patient number: [OD] o/(/O] Oo] \ [z | Visit: feep— Rater initials lo [mje] SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID-I (continued) 036, C. The disturbance is not better accounted for by a Psychotic Disorder that is not ‘substance induced or due to @ general medical condition. Ifthe disturbance is better accounted for by a non-substance-induced psychotic disorder. return to the disorder being evaluated, Evidence that the symptoms are better accounted for by @ Psychotic Disorder that is not substance induced include: (1) the psychotic symptoms precede the onset of the substance or medication use or the general medical condition (2) the psychotic symptoms persist for a substantial period of time (e.g., about a month) after the cessation of acute withdrawal or severe intoxication (8) the psychotic symptoms are substantially in excess of what wouid be ‘expected given the type or amount of the substance used or the duration of use. (4) there is other evidence that suggests the existence of an independent non- ‘substance-induced Psychotic Disorder (e.g., a history of recurrent non- substance related psychotic episodes). No Yes 30 CRITERIA A, B, AND C ARE MET (MAKE A DIAGNOSIS OF SUBSTANCE INDUCED PSYCHOTIC DISORDER OR DUE TO A GENERAL MEDICAL CONDITION.) Yes u Excluded END SCID PSYCHOTIC DISORDER NOT OTHERWISE SPECIFIED c3t This category should be used to diagnose psychotic symptomatology (ie. Gelusions, hallucinations, disorganized speech, grossly disorganized or catatonic Behavior) about which there is inadequate information to make a specif diagnosis oF about which there is contradictory information, or disorders with peychotic, ‘symptoms that do not meet the criteria for any specific Psychotic Disorder defined | above. No Yes u a oF Excluded i END scID | 090027 “Ss CONFIDENTIAL Page 26 Version 1.0 §/3/2002SOURCE DOCUMENT THIS IS NOTA CRF Pat nt initials: [> [2] M] Visit date (mm aa, yyy): [24 [2008] Rater initials 3) Me Site(Patient number: [>| @[{ [of [Olt | Visit: [SCH | SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID-I (continued) D. MOOD DISORDERS BIPOLAR I DISORDER CRITERIA (BPAD) If ihere have never been clinically significant mood symptoms, go to Module E. g D1 | History of 1 or more Manic or Mixed Episodes (see A28) No Yes a NOTE: In a Mixed Episode, the criteria are met for both a Manic Episode anda | Ds Major Depressive Episode (except for duration) nearly every day during at least a “week period D2 | Atleast 1 Manic or Mixed Episode is not due to ihe cirect physiological eects ofa [No Ves general medical condition or substance use, J Ds NOTE: Manic-Like episodes that are clearly caused by somatic antidepressant treatment (e.g., medication, electroconvuisive therapy, light therapy) should not ‘count toward a diagnosis of Bipolar | Disorder. D3] Atleast 1 Manic or Mixed Episode is not better accounted for by Schizoatfectve | NoYes Disorder and is not superimposed on Schizophrenia, Schizophreniform Disorder, | JU Delusional Disorder, or Psychotic Disorder Not Otherwise Specified. C2 _BPAD Excluded END SCID BIPOLAR I! DISORDER CRITERIA (BPAD2) 05 | Atleast 1 Hypomanic Episode is not due to the direct physiological effects ofa [No Yes general medical condition or substance use (including somatic antidepressant u treatment) (see A42) b10 D6 | Atleast 1 Major Depressive Episode is not due to the direct physiological effects | No Yes of a generat medical condition or substance use (see A14) u p10 7 | There have never been any Manic or Mixed Episodes. No Yes u D109 D8 | The mood symptoms are not better accounted for by Schizoaffective Disorder | No Yes (C15) and are not superimposed on Schizophrenia (C9), Schizophreniform u Disorder (C10), Delusional Disorder (C21), or Psychotic Disorder Not Otherwise BPAD2 ‘Specified (C31). Excluded END SCID duvecs cs CONFIDENTIAL Page 27 Version 1.0 5/3/2002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: tolelm Visit date (mm dd, yyy): | (24 [4003 Site/Patient number: [0 | 9) 2] Of ol, 3] visit: [C2] Rater initials Gime SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORI RS CLINICIAN VERSION SCID-I (continued) OTHER BIPOLAR DISORDER CRITERIA (CYCLOTHYMIC DISORDER) (BIPOLAR DISORDER NOS) D10 | Clinically significant manic or hypomanic symptoms, 11 | Not due to the airect physiological effects of a general medical condition or ‘substance (including somatic antidepressant treatment) use. D12 | If UNKNOWN: Have you had [MANIC OR DEPRESSIVE SYMPTOMS] in the past month? Cyclothymic Disorder (must meet all 3 of the following criteria) A. For at least 2 years, the presence of numerous periods with hypomanic ‘symptoms and numerous periods with depressive symptoms that do not meet criteria for a Major Depressive Episode. 5. During the above 2-year period, the person has not been without the symptoms in criterion A for more than 2 months at a time. C. No Major Depressive Episode, Manic Episode, or Mixed Episode has been resent during the first2 years of the disturbance, Bipolar Disorder Not Other ise Specified (for disorders with bipolar features that do not meet criteria for any specific Bipolar Disorder) Ouue 29 es CONFIDENTIAL Page 28 Version 1.0 5/3/2002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: D{2|M) Visit date (mm dd, yyy): (11 2H 1200S Site/Patient number: | o|Q|{1 jO! 0/0 | 1 |s Visit: sok Rater initials sia] SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID-I (continued) 1oa05 oN if MAJOR DEPRESSIVE DISORDER CRITERIA (MDD) 513 | Atleast 1 Major Depressive Episode is not due to the direct physiological effects | No 7 Yes? of a general medical condition or substance use (see A14) we 14 | There has never been a Manic Episode, a Mixed Episode, or a Hypomanic No Yes. Episode (not accounted for by schizoaffective disorder). ive NOTE: In a Mixed Episode, the criteria are met for both a Manic Episode and a Major Depressive Episode (except for duration) neariy every day during at least a 4-week period. 15 | Patient has met diagnostic criteria for Major Depressive Disorder in lifetime, ve an “If MDD is co-morbid with schizophrenia, score on SCID/Psychiatric History | 016 MDD* ‘source document. If current MDD with psychotic features, exclude from project. DEPRESSIVE DISORDER NOS CRITERIA B16 | Clinically significant depressive symptoms do not meet criteria for a specific No” Yes Depressive Disorder or Adjustment Disorder and are not better accounted for by Bereavement DI7_| Not due to tne direct physiological effects of a general medical condilion or No Yes |__| substance (including somatic antidepressant treatment) use. D'8 | Depressive Disorder Not Otherwise Specified No Yes (Not scored on SCIDiPsychiatric History source documen 3 0uuu30 CONFIDENTIAL, Page 20 Version 1.0 5/3/2002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: [> 1M] visit date (mm ad, yyy: [py [00 Site/Patient number: [9 oli fole of 3] Visit: EC] Rater initials b le} SELECTED SECTIONS* OF THE INICAL INTERVIEW FOR DSI CLINICIAN VERSION SCID-1 (continued) STRUCTURED CLI £- ALCOHOL AND OTHER SUBSTANCE USE DISORDERS M-IV AXIS 1 DISORDERS Et | Mat are your drinking habits tke? (How | inthe past S years haw had a period of you din) Te Ney eylowaten) (What do. | excessive drinking OR had eomeree ot you drink?) IF NOT CURRENTLY alcohol-related problems, DRINKING HEAVILY: In your lifetime has. there been a time when you were drinking a lot more? (How often were you drinking) (What were you drinking? How much? How ‘ong did that period last?) (Curtentiy/Ouring thet time...) (doesidid) your drinking cause problems e for you? |_..(d0es/dd) anyone objec to your drinking? ALCOHOL DEPENDENCE CRITERIA fae A. Iniifetine a maladaptive pattem of |? No Yes alcohol use, leading to clinically significant impairment or distress, as manifested by 3 (or more) of the foltowing occurring at any time in the same 12-month perio: £2 rer ne ask You 3 few more questions about | (3) alcoho is ofen taken larger ? No Yes [TIME WHEN DRINKING MOST/TIME ‘amounts OR over a longer period than WITH MOST PROBLEMS). During that | was intenaeu time... Have you often found that when you started drinking you ended up drinking much more : than you were. planning to? IF NO: What about drinking over a much longer period of time than you were planning to? E3 | Have you tried to cut down or stop drinking | (4) there is a persistent desire OR 2? No Yes alcohol? unsuccessful efforts to cut down or If YES: Did you ever actually siop drinking | control substance use altogether? (How many times did you try to e cut down or stop altogether’) Uduul2 cs CONFIDENTIAL Page 30 Version 1.0 5/3/2002es = es es Me SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: [D|@|M] visit date (mm ad, yyy): | {1 UY | 2003 Site/Patient number: [O [0/1 | 010] Olt [& Visit: GOR Rater initials 3) ald SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID-I (continued) £4 | Have you spent a iot of ime drinking, being | (6)a great deal of ime iw spantin” > No Yes high, or hung over? activites necessary to obtain alcohol, use alcohol, or recover from is effects E5 | Have you had times when you would drink | (6) important social, occupational, or |? No Yes 0 often that you started to drink instead of | recreational activities are given up or working, spending time with your family or | reduced because of alcohol use friends, or engaging in other important activities, such as sports, gardening, or playing music? 6 | IF NOT ALREADY KNOWN: Has your (7) alcohol use is continued despite |? No Yes drinking ever caused any psychological knowledge of having a persistent or problems such as making you depressed or | recurrent physical or psychological anxious, making it hard to sleep, or causing | problem that is ikely to have been "blackouts" ‘caused or exacerbated by alcohol IF NOT ALREADY KNOWN: Has your (eg, continued drinking despite drinking ever caused significant physical recognition that an ulcer was made problems or made a physical problem ‘worse by alcohol consumption) worse? IF YES TO EITHER OF ABOVE: Did you keep on drinking anyway? _| £7 _| Have you found that you needed to drink a (1) tolerance, as defined by either of |? No Yeo lot more in order to get the feeling you the following: wanted than you did when you frst started | (a) a need fer markedly increased drinking? amounts of alcohol to achieve IF YES: How much more? intoxication or desired etfect 1F NO: What about finding that when you | (0) markedly diminished effect with the rank the same amount, it had much less continued use of the same-amount effect than before? ‘of alcoho! Obuu3y cy CONFIDENTIAL Page 31 Version 1.0 5/3/2002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: DEIN] visit date (mm dd, yyyy): | fl 24 \oog Site/Patient number: [910 [t |OTOlO|l [2 visit: [6c 2} Rater initials Ly Jmj 4 SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID-I (continued) 8 | Have you had any withdrawal symptoms | (2) withdrawal, as manifested by elther |? No Yes when you cut down or stopped drinking (@)or (bo) such as. (@) atleast 2 of the following ‘sweating or racing heart? developing within several hours to hand shakes? a few days after cessation of (or reduction in) heavy and prolonged trouble sleeping? feeling nauseated or vomiting? alcohol use: -automatic hyperactivity (e.9., sweating feeling agitated? or pulse rate greater than 100) ‘or feeling anxious? -increased hand tremor (How about having a seizure or seeing, | insomnia fing. ‘or hearing things that weren't 2ally | ace or vomiting IF NO: have you ever started the day with a | “PS¥chomotor agitation drink, or did you often drink or take some | -anxiety cther drug or medication to keep yourself | -grand mal seizures from geting the shakes or becoming sick? | transient visual, tactle, or auditory hallucinations or ilusions (©) alcohol (or a substance from the sedative/hypnotic/anxiolytic class) taken to relieve or avoid withdrawal | symptoms £9 | IF UNKNOWN: When did [SYMPTOMS | IN LIFETIME, AT LEAST 3 No Yes RATED "Yes" ABOVE] occur? (Did they all | DEPENDENCE ITEMS (E2-£8) ARE | J. happen around the same time?) "Yes" AND OCCURRED WITHIN THE | E19 ‘SAME 12-MONTH PERIOD Patient has met diagnostic criteria for Atcohol Dependence in lifetime, (Score on SCID/Psychiatric History source document.) ACTIVE IN PAST MONTH. No Yes oo ou E15 £15 Qoyus? es CONFIDENTIAL Page 32 Version 1.0 5/3/2002SOURCE DOCUMENT THIS IS NOTA CRF Patient initials: D [AM] visit date (mm da, yyyy): | tt 24 [203 | Site/Patient number: | 0] d| 1 | 0] O Rater initials ots Visit: > [ol 4 SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS. CLINICIAN VERSION SCID-| (continued) ALCOHOL ABUSE CRITERIA Now I would like to ask you some more A. Inthe past 6 years, a maladaptive questions about your drinking Pattern of substance use leading to Cinically significant impairment or distress as manifested by one (or ore) ofthe following occurring within ‘a t2-month period, E10 | In your lifetime have you ever missed work | (1) recurrent alcohol use resulting na 1? No Yeo Or school because you were intoxicated, _| failure to fulfil major role obligations at high, or very hung over? (How often? ‘work, schoo), or home (e.g. repeated ‘What about doing a bad job at work or absences or poor work performances failing courses at schoo! because of your drinking?) IF NO: What about not keeping your house clean or not taking proper care of your children because of your drinking? (How often?) E11 | In your ifetime have you ever had a drink in | (2) recurrent alcohol use in situation in|? No Yee 2 situation in which it might have been which itis physically hazardous (e.g., dangerous to drink at all? driving an automobile or operating a (Did you ever drive while you were really too | Machine when impaired by alcohol __| drunk to drive?) use) £12 | In your lifetime did your drinking get you ito | (3) recurrent alcoholselated egal |? No Yes trouble with the law? (Tell me more about | problems (e.g, arrests for alconol- that.) related disorderly conduct) JF YES: How many times? eae £13 | INNOT ALREADY KNOWN: In your lfetime | (4) continued alcohol use despite ? No Yes did your drinking cause problems with other | having persistent or recurrent social or people, such as with family members, interpersonal probiems caused or friends, or people at work? (Have you ever | exacerbated by the effects of alcohol gotten into physical fights when you were | (e.g., arguments with spouse about drinking? What about having bad ‘consequences of intoxication, physical arguments about your drinking?) fights) IF YES: Did you keep on drinking anyway? E14 | IN YOUR LIFETIME AT LEAST ONE ABUSE ITEM (E10-£13) IS "Yes" No Yes Patient has met diagnostic criteria for Alcohol Abuse in his/her lifetime (Score on SCiD/Psychiatric History source document) MET CRITERIA FOR ALCOHOL ABUSE IN PAST MONTH No. Yes Uddus3 CONFIDENTIAL Page 33 cs Version 1.0 5/3/2002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: LD | |W) Visit date (mm dd, yyyy):{ (1 24 hoo? | SitePatient number: |O | 0 |! | 00/0] (13 Visit: sk} Rater initials we} SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID4 (continued) NONALCOHOLIC SUBSTANCE USE DISORDERS E15 | Inthe past 5 years have you taken any of | B. In ifetime a maladaptive pattern of aye these to get high, to sleep better, to lose _| substance use, leading to clinically ‘weight, oF to change your mood? (SHOW _ | significant impairment or distress, 2s FA DRUG LIST ON LAST PAGE OF THIS manifested by one (or more} of the SOURCE DOCUMENT TO PATIENT AND | foliowing occurring at any time in the RECORD INFORMATION ON same 12-month period SCORESHEET,) __| ‘Which one caused you the most problems? | INDICATE DRUG CLASS WITH HEAVIEST IF DENIES PROBLEMS: Which one did | USE/MOST PROBLEMS: you use the most? NONALCOHOLIC SUBSTANCE DEPENDENCE E16 | | would now lke to ask you some questions | (3) the substance is often taken in 7 No Yes about your use of [DRUG]. Farger amounts OR over a longer Have you often found that when you started | Period than was intended using [DRUG] you ended up using much more than you were planning to? IF NO: What about using it for a much tonger period of time than you were 1 planning to? E17 | Have you tried to cut down or stop using | (4) there is persistent desire OR 7 No Yes (DRUG}? ‘unsuccessful efforts to cut down or IF YES: Did you ever actually stop using _| control substance use [DRUG] altogether? How many times did you try o cut down or stop altogether?) IF NO: Did you want to stop or cut down? (is this something you kept worrying about?) E18 | Have you spent a lot of time using [DRUG] | (5) a great deal of time is spent in 2 No Yes ‘0 doing whatever you had to do to getit? | activities necessary to obtain the Did it take you a long time to get back to | substance (e.g,, visiting multiple normal? doctors or driving long distances), use the substance, oF recover from its effects OuUUs4 Yuu se CONFIDENTIAL Page 34 Version 1.0 5/3/2002Patient initials: {> [@]an] visit date (mm dd, yyy}: SitePatient number: [10 [1 jo [2 Rater initials aime SOURCE DOCUMENT THIS IS NOT A CRF wos | dis SELECTED SECTIONS" OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID-I (continued) E19 | Have you had times when you would use | (6) important social, occupational, or]? No Yes [DRUG] so offen that you started to use _| recreational activities are given up or [DRUG] instead of working, spending time _| reduced because of substance use with your family or friends, or engaging in ther important activities, such as sports, gardening, or playing music? 20 | IF NOT ALREADY KNOWN: Has your drug | (7) the substance use is continued |? No Yes use ever caused any psychological despite knowledge of having a problems such as making you depressed or | persistent or recurrent physical or anxious, making it difficult to sleep, or Psychological problem that is likely to causing “blackouts”? have been caused or exacerbated by IF NOT ALREADY KNOWN: Has your drug_| the substance (e.g., current cocaine Use ever caused significant physical tse despite recognition of cocaine- problems or made a physical problem induced depression) worse? IF YES TO EITHER OF ABOVE: Did you keep on using anyway? E21 | Have you found that you needed touse a | (1) Tolerance, as defined by ether of |? No Yes lot more [DRUG] in order to get the feeling the following: you wanted than you did when you first | (a) a need for markedly increased Started using it? amounts of the substance to IF YES: How much more? ‘achieve intoxication or desired IF NO: What about finding that when you effect Used the same amount, ithad much less | (b) markedly diminished effect with effect than before? continued use of the same amount cof the substance eS ) cs CONFIDENTIAL Page 35 Version 1.0 5/3/2002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: [> [2 |M] visiedate (mmad, yyy):[ 1 24 1028, SiteyPatient number: [0 [0 |t [O]0 | 0] [> visit: [sc#-] Rater initials Lb Tm] " SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID-4I (continued) £22 | THE FOLLOWING MAY NOT APPLY TO | (2) withdrawal, as manifested by 7 No Yes CANNABIS, HALLUCINOGENS, AND. either (a) or (b): PHENCYCLIDINE. (a) the characteristic withdrawal Have you ever had any withdrawat syndrome for the substance (see ‘symptoms, that is, felt sick when you cut next page for descriptions) down or stopped using [DRUG]? (b) the same (or closely related) IF YES: What symptoms did you have? substance is taken to relieve or [REFER TO LIST OF WITHDRAWAL avoid withdrawal symptoms SYMPTOMS ON PAGE 28) IF HAD WITHDRAWAL SYMPTOMS: After not using [DRUG] for a few hours or more, have you often used it to keep yourself from getting sick with [WITHDRAWAL SYMPTOMS]? ‘What about using [DRUG IN SAME CLASS] when you were feeling sick with [WITHDRAWAL SYMPTOMS] so that you would feel better? 23. | IF UNKNOWN: When did [SYMPTOMS | IN LIFETIME AT LEAST 3 No Yes RATED “Yes” ABOVE] occur? (Did they all | DEPENDENCE ITEMS (E16-E22) u happen around the same time?) ‘ARE “Yes AND OCCURRED WITHIN | pq ‘THE SAME 12-MONTH PERIOD. (Score on SCID/Psychiatric History ‘source document) IF YES, INDICATE SUBSTANCES): __marijuana oveaine opiates “Pcp amphetamines. —_other, specify ‘ACTIVE IN PAST MONTH No Yes ooY FLoFt Quuusd ray CONFIDENTIAL Page 36 Version 1.0 6/3/2002Pati Rater initials Dim] 4 ient initials: PIR WM] visita SOURCE DOCUMENT THIS IS NOTA CRF late (mm dd, yyy): | (1 | 24 [2P08 Patient number: [o alt joo O14 ce SELECTED SECTIONS* OF THE : STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID-I (continued) NONALCOHOLIC SUBSTANCE ABUSE CRITERIA (1) recurrent substance use resulting in | ? No Yes £24 | Now I'd lke to ask you some more uestions about your use of [DRUG USED | a failure to full major role obligations THE MOST OR GAUSED THE MOST at work, schoo), or home (e.g, PROBLEMS} Tepeated absences or poor work In the past 5 years have you missed work or | Performance related to substance use; ‘school because you were high or very hung | Substance-related absences, over? (How often?) (What about doing a | Suspensions, or expulsions from bag job at work or falling courses at schoo! | School; neglect of chidren or because you used [Drug rousehols). £26 | In the past § years have you used [DRUG] _| 2) recurrent substance use in 7 No Yes ina stuation in which it might have been | situations in which t physically dangerous? (have you ever driven when | hazardous (e.g, driving an automobile you were really too high to drive?) o° operating @ machine when impaired IF YES: How often? (When?) by substance use) £26 | Inthe past 5 years has your use of [DRUG] | (2) recurrent substancevelated legal? No Ves] gotten you int trouble withthe law? problems (e.g. arrests for substance- IF YES: How often? (When?) {elated disorderly conduct) 27 | IF YES: Did you keep on using [DRUG] | (4) continued substance use despte |? No Yes anyway? having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects ofthe substance (e.g., arguments with spouse about the consequences of intoxication, physical fights) £28 [ATLEAST 1 ABUSE ITeMEZaez7 IS | NO YES “Yes" (MAKE A DIAGNOSIS OF ‘SUBSTANCE ABUSE DISORDER) (Score on SCID/Psychiatric History source document) iF YES, INDICATE SUBSTANCE(S): _matjuana i eseaine opiates Per amphetamines other, specify ACTIVE IN PAST MONTH No_YEs buuus7 cs CONFIDENTIAL Page 37 Version 1.0 5/3/2002SOURCE DOCUMENT THIS IS NOT A CRF Patient initials: |D[A |} Visit date (mm ad, yyyy): | 1( — [24 [2003 Site/Patient number: Q | 0 |\ | 0] o| of 1 [3 Visit: (gc 2} Rater initials fo te[4 SELECTED SECTIONS* OF THE STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS | DISORDERS CLINICIAN VERSION SCID-I (continued) LIST OF WITHDRAWAL SYMPTOMS (FROM DSM-IV CRITERIA) Listed below are the characteristic withcrawal symptoms for those classes of substances for which a withdrawal syndrome has been identified. (NOTE: A specific withdrawal syndrome has not been identified for cannabis and hallucinogens/PCP.) Withdrawal symptoms may occur folowing the cessation of prolonged moderate or heavy Use ‘of a substance or a reduction in the amount used. ‘SEDATIVES, HYPNOTICS, AND ANXIOLYTICS: Two (or more) ofthe following, developing within severel hours to 2 few days after cessation (or reduction) of sedative, hypnotic, or anxiolytic use, that has been heavy and prolonged: 1. autonomic hyperactivity (e.g, sweating or pulse rate greater than 100) 2. increased hand tremor 3. insomnia nausea or vomiting transient visual, tactle, or auditory hallucinations or ilusions. psychomotor agitation anxely ‘grand mal seizures STIMULANTSICOCAINE: Dysphoric mood AND 2 (or more) ofthe folowing physiological changes, developing ‘within afew hours to several days after cessation (or reduction of stimulant or cocaine use hal has deen Reavy and prolonged): fatigue vivid, unpleasant creams insomnia or hypersoraia increased appetite psychomotor retardation or agtation OPIOIDS: Three (or more) ofthe following, developing within minutes to several days after cessation (or reduction) (of opioid use that has been heavy and prolonged (several weeks or longer) or after administration of an opioid antagonist (after a period of opioid use) 1. dysphoric mood 2. nausea or vomiting 3. muscle aches laccmation or tinorthea pupilry dation, ploerecton or sweating Giathea yawning fover Ouuuss insomnia eenoas os CONFIDENTIAL Page 38 Version 4.0 6/3/2002SOURCE DOCUMENT THIS IS NOT A CRF Pationt initials: DI|M | Visit date (mm dd, yyy): | 41 [zy |z0os SiterPatient number: [ OT | 1 Jo [ol o! 1 [3] Visit: [ec Rater initials a Tale SELECTED SECTIONS* OF THE CLINICIAN VERSION SCID-I (continued) F. ANXIETY AND OTHER DISORDERS OBSESSIVE-COMPULSIVE DISORDER STRUCTURED CLINICAL INTERVIEW FOR DSM-IV AXIS I DISORDERS. a FI | Now | would like to ask youl inyour | Obsessions are defined by (1), @). @) (re) es lifetime, you have been bothered by and (4): though that ci not make any sense and | (1) current and persistent thoughts, kept coming back to you even when you | {npuisas or mages ssen tua Fe tried not to have them? ‘experienced, at some time during the (What were they?) disturbance, as intrusive and |F PATIENT NOT SURE WHAT IS MEANT: | inappropriate and that cause marked Thoughts like hurting someone even anxiety or distress though you really did not want to, or being {contaminated by germs or dirt? oo F2 (2) the thoughts, impulses, or images ? No Yes are not simply excessive worries about | | Featite problems Fs 3. | When you had these thoughis, dd you ty | (@) the person attempts fo gnare or 17 No Yoo] hard to get them out of your head? (What | suppress such thoughts, impulses, or v ‘would you try to do?) images or toneutraze them with some | other thought or action i F4 | IF UNCLEAR: Where do you think these | (4) the person recognizes that the 2 No Yes thoughts are coming from? obsessional thoughts, impulses, or J Images are a product of his or her own mind (not imposed from without as in 6 thought insertion). FS OBSESSIONS (1), (2), (3), AND (4) ? No Yes | ARE “Yes” F6 | In your ifetime wes there ever anything that | Compulsions as defined by (iy and (@y es | you had to do over and over again and Could not resist doing, such as washing yur hanes again and again, couning upto | {")epeitve benavons (eg, hand | | Fe a certain number, or checking something 2ets (eyes nng. checking) or ment at several imes to make sure you had done it | 2! (praying, counting, repeating words Tight? silently) thatthe person feels driven to Perform in response to an obsession, or according to certain rules that must be (What did you have to do?) applied rigidly Guus cs CONFIDENTIAL Page 39 Version 1.0 5/3/2002