Impact of GeneSight Psychotropic on Response to Psychotropic Treatmen...

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Trial record 13 of 31 for:

Open Studies | "Mood Disorders" | United States, Georgia

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Impact of GeneSight Psychotropic on Response to Psychotropic Treatment in Outpatients Suffering From a Major
Depressive Disorder (MDD) and Having Had an Inadequate Response to at Least One Psychotropic Medication Included in
GeneSight Psychotropic (RCT)
This study is currently recruiting participants. (see Contacts and Locations)

ClinicalTrials.gov Identifier:

NCT02109939

Verified April 2015 by AssureRx Health, Inc.

First received: April 4, 2014

Last updated: April 22, 2015
Last verified: April 2015
History of Changes

Sponsor:

AssureRx Health, Inc.

Collaborator:

University of Michigan
Information provided by (Responsible Party):

AssureRx Health, Inc.

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Purpose
Evaluate the impact of GeneSight Psychotropic on response to psychotropic treatment as judged by the mean change in the 17-item Hamilton Depression (HAM-D17) score
from baseline to end of Week 8 of the study.

Condition

Intervention

Phase

Major Depressive Disorder (MDD)

Genetic: GeneSight Psychotropic

Phase 4

Study Type:
Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title:

A 12-Week, Randomized, Double-Blind, Controlled Evaluation Followed by an Open-Label 12-Week Follow-up Period of the Impact of GeneSight
Psychotropic on Response to Psychotropic Treatment in Outpatients Suffering From a Major Depressive Disorder (MDD) and Having Had - Within the
Current Episode - an Inadequate Response to at Least One Psychotropic Medication Included in GeneSight Psychotropic

Further study details as provided by AssureRx Health, Inc.:

Primary Outcome Measures:

17-item Hamilton Depression (HAM-D17) score [ Time Frame: from baseline to end of Week 8 ] [ Designated as safety issue: No ]
Evaluate the impact of GeneSight Psychotropic on response to psychotropic treatment as judged by the mean change in the 17-item Hamilton Depression (HAM-D17)
score from baseline to end of Week 8 of the study.

Secondary Outcome Measures:

16-item Quick Inventory of Depression Symptomology (QIDS-C16) scale [ Time Frame: from baseline to end of Week 8 ] [ Designated as safety issue: No ]
Mean change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) scale or the 9-item Patient Health Questionnaire (PHQ-9) from baseline to end
of Week 8 of the study;
Percentage of responders at Week 8 for HAM-D17 [ Time Frame: Week 8 visit info ] [ Designated as safety issue: No ]
Percentage of responders at Week 8 in each treatment group on the HAM-D17. A responder is defined as a participant with 50% change from baseline in total scale
score;
Percentage of responders at Week 12 for HAM-D17 [ Time Frame: Week 12 visit info ] [ Designated as safety issue: No ]
Percentage of responders at Week 12 (defined as above) in each treatment group on the HAM-D17
Percentage of remitters at Week 12 defined as HAM-D17 7 [ Time Frame: week 12 visit info ] [ Designated as safety issue: No ]
Percentage of remitters at Week 12 defined as HAM-D17 7
Percentage of remitters at Week 8 defined as HAM-D17 7 in each treatment group; [ Time Frame: week 8 visit info ] [ Designated as safety issue: No ]
Percentage of remitters at Week 8 defined as HAM-D17 7 in each treatment group;
Time to response/remission of depressive symptoms over 8 weeks; [ Time Frame: week 8 and 12 visit info ] [ Designated as safety issue: No ]

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Time to response/remission of depressive symptoms over 8 weeks;

Mean change in symptoms from baseline to week 24 across all scales in each treatment group. [ Time Frame: Baseline to week 24 visits ]
[ Designated as safety issue: No ]
Mean change in symptoms from baseline to week 24 across all scales in each treatment group.
Percentage of responders at Week 8 for QIDS-C16 [ Time Frame: Week 8 visit info ] [ Designated as safety issue: No ]
Percentage of responders at Week 8 in each treatment group on the QIDS-C16. A responder is defined as a participant with 50% change from baseline in total scale
score;
Percentage of responders at Week 8 for PHQ-9 [ Time Frame: Week 8 visit info ] [ Designated as safety issue: No ]
Percentage of responders at Week 8 in each treatment group on the PHQ-9. A responder is defined as a participant with 50% change from baseline in total scale score;
Percentage of remitters at Week 12 defined as QIDS-C16 5 [ Time Frame: week 12 visit info ] [ Designated as safety issue: No ]
Percentage of remitters at Week 12 defined as QIDS-C16 5
Percentage of remitters at Week 12 defined as PHQ-9 <5 [ Time Frame: week 12 visit info ] [ Designated as safety issue: No ]
Percentage of remitters at Week 12 defined as PHQ-9 <5
Percentage of remitters at Week 12 defined as CGI-S 1 [ Time Frame: week 12 visit info ] [ Designated as safety issue: No ]
Percentage of remitters at Week 12 defined as CGI-S 1
Percentage of responders at Week 12 for QIDS-C16 [ Time Frame: Week 12 visit info ] [ Designated as safety issue: No ]
Percentage of responders at Week 12 (defined as above) in each treatment group on the QIDS-C16
Percentage of responders at Week 12 for PHQ-9 [ Time Frame: Week 12 visit info ] [ Designated as safety issue: No ]
Percentage of responders at Week 12 (defined as above) in each treatment group on the PHQ-9
Percentage of responders at Week 12 for CGI-S [ Time Frame: Week 12 visit info ] [ Designated as safety issue: No ]
Percentage of responders at Week 12 (defined as above) in each treatment group on the CGI-S (defined as a change in category of severity of at least 1 point),
Percentage of responders at Week 12 for CGI-I [ Time Frame: Week 12 visit info ] [ Designated as safety issue: No ]
Percentage of responders at Week 12 (defined as above) in each treatment group on the Clinical Global Impression of Improvement (CGI-I; defined as a score from 1 to
3),
Percentage of responders at Week 12 for CGI-EI [ Time Frame: Week 12 visit info ] [ Designated as safety issue: No ]
Percentage of responders at Week 12 (defined as above) in each treatment group on the Clinical Global Impression of Efficacy (CGI-EI; defined as a scores of 01, 02,
05, or 06);
Percentage of remitters at Week 8 defined as QIDS-C16 5 in each treatment group; [ Time Frame: week 8 visit info ] [ Designated as safety issue: No ]
Percentage of remitters at Week 8 defined as QIDS-C16 5 in each treatment group;
Percentage of remitters at Week 8 defined as PHQ-9 <5 in each treatment group; [ Time Frame: week 8 visit info ] [ Designated as safety issue: No ]
Percentage of remitters at Week 8 defined as PHQ-9 <5 in each treatment group;
Time to response/remission of depressive symptoms over 12 weeks; [ Time Frame: week 8 and 12 visit info ] [ Designated as safety issue: No ]
Time to response/remission of depressive symptoms over 12 weeks;
Mean percent response from baseline to week 24 across all scales in each treatment group. [ Time Frame: Baseline to week 24 visit info ]
[ Designated as safety issue: No ]
Mean percent response from baseline to week 24 across all scales in each treatment group.
Mean percent remission from baseline to week 24 across all scales in each treatment group. [ Time Frame: Baseline to week 24 visit info ]
[ Designated as safety issue: No ]
Mean percent remission from baseline to week 24 across all scales in each treatment group.
Mean change in symptoms from week 12 to week 24 across all scales in each treatment group. [ Time Frame: week 12 to 24 visit info ]
[ Designated as safety issue: No ]
Mean change in symptoms from week 12 to week 24 across all scales in each treatment group.
Mean percent response from week 12 to week 24 across all scales in each treatment group. [ Time Frame: week 12 to 24 visit info ] [ Designated as safety issue: No ]
Mean percent response from week 12 to week 24 across all scales in each treatment group.
Mean change in percent remission from week 12 to week 24 across all scales in each treatment group. [ Time Frame: week 12 to 24 visit info ]
[ Designated as safety issue: No ]
Mean change in percent remission from week 12 to week 24 across all scales in each treatment group.

Estimated Enrollment:

300

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Study Start Date:

April 2014
Estimated Study Completion Date:
February 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms

Assigned Interventions

Active Comparator: GeneSight

Psychotropic Tested

Genetic: GeneSight Psychotropic

Subjects being tested with GeneSight

Psychotropic

The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians to make informed,
evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in
multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications.
The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications,
including a full representation of the SSRI and SNRI drug classes.
tricyclic antidepressants, an MAOI, and typical and atypical antipsychotics are also represented.
Other Names:
Assurex Health
GeneSight

Placebo Comparator: Treatment As

Usual
This group of subjects will not see their
GeneSIght results or know whether or
not they are in either arm.

Genetic: GeneSight Psychotropic

The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians to make informed,
evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in
multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications.
The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications,
including a full representation of the SSRI and SNRI drug classes.
tricyclic antidepressants, an MAOI, and typical and atypical antipsychotics are also represented.
Other Names:
Assurex Health
GeneSight

Show Detailed Description

Eligibility
Ages Eligible for Study:
Genders Eligible for Study:
Accepts Healthy Volunteers:

18 Years and older

Both
No

Criteria

Inclusion Criteria:
Be able to understand the requirements of the study and provide written informed consent to participate in this study; a signed and dated ICF will be obtained from each
patient before participation in the study;
Have provided written authorization for the use and disclosure of their protected health information;
Be 18 years of age;
Suffer from a Major Depressive Episode meeting DSM-IV-TR criteria;
Have had an inadequate response within the current episode to at least 1 psychotropic treatment. Inadequate response is defined as inadequate efficacy after 6 weeks
of a psychotropic treatment or discontinuation of a psychotropic treatment due to AEs or intolerability;
Have a total baseline score on the QIDS-C16 and QIDS-SR16 rating scale 11;
Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study, including all visits and tests.
Exclusion Criteria:
Patients posing a serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator;
Patients with a diagnosis of Bipolar I or II disorder;
Patients with a current Axis I diagnosis of:
a. Delirium
b. Dementia
c. Amnestic and other cognitive disorder
d. Schizophrenia or other psychotic disorder;
Patients having experienced hallucinations, delusions, or any psychotic symptomatology within the current depressive episode or during prior depressive episodes;
Patient is currently in an inpatient facility;
Patients with a history of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months;
Patients who meet DSM-IV-TR criteria for any significant current substance use disorder;
Patients with significant unstable medical condition; life threatening disease; hepatic insufficiency (3X ULN for AST and/or ALT); liver transplant recipient; cirrhosis of the
liver; need for therapies that may obscure the results of treatment and/or of the study; malignancy (except basal cell carcinoma) and/or chemotherapy within 1 year prior
to screening; malignancy more than 1 year prior to screening must have been local and without metastasis and/or recurrence, and if treated with chemotherapy, without
nervous system complications;
Participation in another clinical trial within 30 days of the screening visit;
Anticipated inability to attend scheduled study visits;
Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol;
Patients with a history of prior pharmacogenomic testing;
Any change in psychotropic medication (including change in dosage) between screening and randomization;

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Patients receiving ECT, DBS or TMS treatment (should a Subject receive any of these treatments they must be discontinued from the study);
Patients who are known to be pregnant or lactating;
Patients with a history of gastric bypass surgery.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about
this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02109939
Hide Study Locations
Locations
United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233
Contact: Richard Shelton, MD 205-975-3442
Principal Investigator: Richard Shelton, MD
Sub-Investigator: Rachel Fargason, MD
Sub-Investigator: Li Li, MD

Recruiting

rshelton@uab.edu

United States, California

Synergy Research Center

Escondido, California, United States, 92025

Terminated

Pharmacology Research Institute

Los Alamitos, California, United States, 90720
Contact: Nader Oskooilar, MD 714-827-3667 noskooilar@priresearch.com
Principal Investigator: Nader Oskooilar, MD
Sub-Investigator: Jeffrey Litzinger, MD

Recruiting

CiTrials
Santa Ana, California, United States, 92705
Contact: Evangelos Coskinas, M.D. 714-979-4101
Principal Investigator: Evangelos Coskinas, M.D.

Recruiting

Coskinas@citrials.com

Stanford School of Medicine

Stanford, California, United States, 94304
Contact: Charles DeBattista, MD 650-723-8324 debattista@stanford.edu
Principal Investigator: Charles DeBattista, MD
Sub-Investigator: Alan Schatzberg, MD
Sub-Investigator: Hugh Brent Solvanson, MD, PhD

Recruiting

United States, District of Columbia

Howard University Hospital Mental Health Clinic

Washington, District of Columbia, United States, 20060
Contact: William B Lawson, MD 202-865-6100 wblawson@howard.edu
Principal Investigator: William B Lawson, MD
Sub-Investigator: Mansoor Malik
Sub-Investigator: Tanya Alim
Sub-Investigator: Kamal Gandotra
Sub-Investigator: Babur Bhatti
Sub-Investigator: Matie Trewe
Sub-Investigator: Urooj Saeed

Recruiting

United States, Florida

Recruiting
Janus Center For Psychiatric Research
West Palm Beach, Florida, United States, 33407
Contact: Janice Miller, MD 561-238-3030 jmillermd@januspsychresearch.com
Principal Investigator: Janice Miller, MD
Sub-Investigator: Madeline Stam, MD
United States, Georgia

Mood and Anxiety Program at Emory University

Altanta, Georgia, United States, 30329
Contact: Boadie Dunlop, MD, MS 404-727-8969
Principal Investigator: Boadie Dunlop, MD, MS
Sub-Investigator: Jeffrey Rakofsky, MD
Sub-Investigator: Yilang Tang, MD, PhD
Atlanta Institute of Medicine and Research
Atlanta, Georgia, United States, 30328
Contact: Angelo Sambunaris, MD 770-817-9200
Principal Investigator: Angelo Sambunaris, MD

Recruiting

bdunlop@emory.edu

Recruiting

a.sambunaris@atlanta-institute.com

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612
Contact: Corey Goldstein, MD 773-330-4332
Principal Investigator: Corey Goldstein, MD
Sub-Investigator: John Zajecka, MD

Recruiting

Corey_goldstein@rush.edu

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United States, Indiana

The Institute of Psychiatric Research

Indianapolis, Indiana, United States, 46202
Contact: John Nurnberger, Ph.D, M.D. 317-274-8844
Principal Investigator: John Nurnberger, Ph.D, M.D
Sub-Investigator: Yokesh Balaraman, M.D.

Recruiting

jnurnberger@iupui.edu

United States, Iowa

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States, 52242
Contact: William Coreyll, MD 319-353-4434
Principal Investigator: William Coreyll, MD

Recruiting

william-coryell@uiowa.edu

United States, Kansas

Kansas University Medical Center- Clinical Trials Unit

Wichita, Kansas, United States, 67214
Contact: Matthew Macaluso, D.O. 316-293-1833
Principal Investigator: Matthew Macaluso, D.O.
Sub-Investigator: Sheldon Preskorn, M.D.

Recruiting

mmacaluso@kumc.edu

United States, Maryland

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21224
Contact: Peter Zandi, PhD 410-614-2686 pzandi1@jhu.edu
Principal Investigator: Peter Zandi, PhD
Sub-Investigator: Francis Mondimore, MD
Sub-Investigator: Leslie Miller, MD

Recruiting

United States, Massachusetts

Geriatric Outpatient Unit- McLean Hospital

Belmont, Massachusetts, United States, 02478
Contact: Brent Forester, MD 617-855-3492 bforester@harvard.mclean.edu
Principal Investigator: Brent Forester, MD
Sub-Investigator: Ben Legesse, MD

Recruiting

Recruiting
UMASS Center for Psychopharmacologic Research and Treatment
Worcester, Massachusetts, United States, 01655
Contact: Anthony Rothschild, MD 508-856-1027 anthony.rothschild@umassmemorial.org
Principal Investigator: Anthony Rothschild, MD
Sub-Investigator: Alison Trexler, MD
Sub-Investigator: Nicole Ross, DO
United States, Michigan

University of Michigan
Ann Arbor, Michigan, United States, 48109
Contact: Melvin McInnis
mmcinnis@med.umich.edu

Recruiting

United States, Minnesota

University of Minnesota
Minneapolis, Minnesota, United States, 55454
Contact: Barry Rittberg, MD 612-273-9813 rittb001@umn.edu
Principal Investigator: Barry Rittberg, MD
Sub-Investigator: David Bond, MD

Recruiting

United States, Missouri

Washington University School of Medicine

St. Louis, Missouri, United States, 63110
Contact: Charles Conway, MD 314-362-0038
Principal Investigator: Charles Conway, MD
Sub-Investigator: Donald Bohnenkamp, MD

Recruiting

conwayc@wustl.edu

United States, New York

SPRI Clinical Trials

Brooklyn, New York, United States, 11235
Contact: Nick Vatakis, MD 718-616-2230
Principal Investigator: Nick Vatakis, MD
Sub-Investigator: Eugeny Fink, MD

Recruiting

nvatakis@spristudy.com

Eastside Comprehensive Medical Center, LLC

New York, New York, United States, 10021
Contact: Ram Shrivastava, MD 212-288-0138
Principal Investigator: Ram Shrivastava, MD

Recruiting

drramshrivastava@aol.com

United States, Ohio

University of Cincinnati Health

Cincinnati, Ohio, United States, 45267
Contact: Erik Nelson, MD 513-558-5115 erik.nelson@uc.edu
Principal Investigator: Erik Nelson, MD
Sub-Investigator: Cheryl McCullumsmith, MD

Recruiting

Cleveland Clinic
Cleveland, Ohio, United States, 44120

Recruiting

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Contact: Amit Anand, MD 216-636-2841

Principal Investigator: Amit Anand, MD
Sub-Investigator: Murat Altinay, MD

https://www.clinicaltrials.gov/ct2/show/study/NCT02109939?recr=Ope...

ananda@ccf.org

Ohio State University Department of Psychiatry

Columbus, Ohio, United States, 43210
Contact: Subhdeep Virk, M.D. 614-293-7109
Principal Investigator: Subhdeep Virk, M.D.
Sub-Investigator: Jessica Lammers, M.D.
Sub-Investigator: Samar McCutcheon, M.D.
Sub-Investigator: Amy Thompson, M.D.
Sub-Investigator: Rita Aouad, M.D.
Sub-Investigator: Kevin Reeves, M.D.

Recruiting

subhdeep.virk@osumc.edu

Midwest Clinical Research Center

Dayton, Ohio, United States, 45417
Contact: Bernadette D'Souza, MD 937-424-1050
Principal Investigator: Bernadette D'Souza, MD
Sub-Investigator: Otto Dueno, MD
Sub-Investigator: Jeffrey Bishop, MD

Recruiting

bdsouza@midwestclinical.com

United States, Oklahoma

Oklahoma Clinical Research Center

Oklahoma City, Oklahoma, United States, 73112
Contact: Marvin L Peyton, M.D. 405-753-4994 drpeyton@okcrc.net
Principal Investigator: Marvin L Peyton, MD

Recruiting

United States, Pennsylvania

Suburban Research Associates

Media, Pennsylvania, United States, 19063
Contact: Shirkumar Hatti, M.D. 610-891-9024
Principal Investigator: Shirkumar Hatti, M.D.
Sub-Investigator: Sudha Nair, M.D.

Recruiting

Shatti@suburbanresearch.com

Mood and Anxiety Disorders Treatment and Research

Philadelphia, Pennsylvania, United States, 19104
Contact: Michael Thase, MD 215-746-6680 thase@mail.med.upenn.edu
Principal Investigator: Michael Thase, MD
Sub-Investigator: Mario Cristancho, MD
Sub-Investigator: Mahendra T Bhati, MD
Sub-Investigator: Theodore Satterthwaite, MD

Recruiting

United States, Texas

Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 76034
Contact: Mustafa Husain, M.D. 214-648-2806 mustafa.husain@utsouthwestern.edu
Contact: Ahmad Raza, MD PHD 214-648-2806 ahmad.raza@utsouthwestern.edu
Principal Investigator: Mustafa Husain, MD
Sub-Investigator: Raza Ahmad, MD PHD

Baylor College of Medicine

Houston, Texas, United States, 77030
Contact: Asim Shah, MD 713-873-5270
Principal Investigator: Asim Shah, MD
Sub-Investigator: Sanjay Mathew, MD

Recruiting

aashah@bcm.edu

United States, Washington

Frontier Institute
Spokane, Washington, United States, 99204
Contact: John Tran, MD 509-710-8750 jtranfi@smhca.org
Principal Investigator: John Tran, MD
Sub-Investigator: Melody Stupey, MD

Recruiting

Sponsors and Collaborators

AssureRx Health, Inc.

University of Michigan
Investigators

Principal Investigator: John Greden, Ph.D

University of Michigan

More Information
No publications provided
Responsible Party:
AssureRx Health, Inc.
ClinicalTrials.gov Identifier: NCT02109939 History of Changes
Other Study ID Numbers:
ARX1006
Study First Received:
April 4, 2014
Last Updated:
April 22, 2015
Health Authority:
USA: INC Research
USA: Copernicus Group IRB
Keywords provided by AssureRx Health, Inc.:

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MDD
Pharmacogenomic
Pharmacogenomic Testing
Pharmacogenomics
Genetic Testing
Genetics
Major Depressive Disorder

GeneSight
Assurex
AssureRx
Psychotropic
Randomized
Double Blind
Placebo Controlled

Additional relevant MeSH terms:

Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders

Mood Disorders
Psychotropic Drugs
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on June 09, 2015

6/11/2015 1:08 AM