-I

for Unanticipated Problems Involving Risks t

ectsor Others

0709M16844
[Charles Schulz, MD
Seroquel XR for the Management of Borderline
Personality Disorder (BPD) ____

IRB S tudy Number:

Current Principal Investigator.
Primary Title:

Provide the following information for each unanticipated problem/event that is serious and
possibly related to the research procedures. Attach any summary or report from sponsor or
DSMB with corresponding reference #.

Reference
Date of Event:
Date of Report:
On-site

Astrazeneca Study #IRUSQUET0454

2010
2010
Off-site

Initial report

Follow up report

Describe problems/event:
Misuse of study medication: study medication misused by two study subjects and given to others.
Incident report included with this document.
Possibly related LIII Probably related LII Definitely related
Does this problem/event alter risk to past, present or future subjects?
Yes III
Dont Know (Insufficient Information)
No El

E]

Based on your, the local investigators judgment, should this problem/event be added to the
consent form as a potential risk?
Yes
LIII Provide revised consent form with changes highlighted.
Z Explain why not:
No
The incident did involve a direct risk to study subjects taking the study medication.

Based on your, the local investigators, analysis of this problem/event,

should currently enrolled subjects be notified?
YeSEI
should subjects who have completed the study be notified?
Yes [11111
Explain:
The safety of the two study subjects was not affected by this incident.

Principal InvestigatorSit

Date

No
No

Study: Seroquel XR for the Management of Borderline Personality Disorder

(BPD)

1YJ (1

P: S. Charles Schulz, MD

till,
l,i1iIItrr1Th
Date of Report:

ISIISJ

Study patient
was enrolled into study on
2010 and
randomized to study medication (Seroquel XR or placebo) on
2010,
current residence was Alpha House Residence. Alpha House is a
residential program which provides high levels of structure and supervision for
sex offenders within a therapeutic community setting and is licensed and certified
by the Minnesota Department of Corrections.
Study patient
was enrolled in study on
2010 and
randomized to study medication on
2010.
current residence was
Alpha House Residence,
returned to research clinic for study visit 3 on
2010.
did not return visit 2 study medication bottle stating he forgot
it at home.
eminded to return study med bottle at next visit and he agreed.
received visit 3 assessments and new bottle of study medication was
dispensed to him, Seroquel XR or placebo, 30 tablets with instructions to take 3
tablets at bedtime (150mg or placebo).
did not return to study visit 4 on
2010. Study coordinator phoned Alpha House residence line and
was not available. Study coordinator left message regarding
missed
appointment. Study coordinator then received a phone call from
who was
calling in for final follow-up after study withdrawal,
informed study
coordinator that
had gone back to prison on
2010.
On Tuesday
2010 Study coordinator received phone call from
acquaintance of
stating
iad got locked up again. Study coordinator
received second phone call from Alpha House staff person Alexis stating
had signed a release of information for study staff. Alexis stated
had been
re-imprisoned due to an incident involving the study medication as follows.
reported to Alpha House staff that he had only taken 1 dose of his study
medication (1 tablet of Seroquel XR 50mg or placebo) and did not like the effects
of the medication. He then gave
6 tablets of his study medication.
returned to research clinic for visit 3 on 18 MAY 2010 and returned his bottle of

stated he felt overly sedated by

study medication with 3 tablets remaining,
the study medication, and did not wish to continue in the study.
was employed as the full-time cook at Alpha House, Per Alexis on the
morning of
2010 BRE cooked and served oatmeal to 1520 persons at
Alpha House, 4 of which were staff members. Some residents noticed pink
particles in the oatmeal. After eating breakfast the residents and staff reported
feeling sedated and some were knocked out for the remainder of the day.
Staff asked
if he had put the study medication into the oatmeal and
denied it. After failing a polygraph test
was re-imprisoned.
Study medication blind was broken by Investigational Drug Services (IDS)
pharmacy at the University of Minnesota on
2010. Blind reveals
was randomized to Seroquel 150mg arm and
was randomized to
Seroquel 300mg arm. Both arms start out on daily dose of Seroquel XR 50mg at
bedtime for I week, and then increase to 150mg at bedtime for 2 weeks.
Remaining study drug for kits
pharmacy for destruction.

and

to be returned to IDS

UNIVERSITY OF MINNESOTA
Twin Cities Campus

Human Research Protection Program

011ice ofthe Viii I,rsjclejt! fm Research

/)528 Maya Memorial Building

420 Delawase Street S. E
MMC 820
Minneapolis. MN 55455
Office: 6/2-626-5654
Icv. 612-620-6061
E-mail: jib @ scm/s. edo or jbc @ cmiii es/is
IVebsile: Iinp://researcli. (s,,in.edf/sisbfcts/

06/21/2010
Sellmann C Schulz
Psychiatry Department
F282/2A West-B
2450 Riverside
Minneapolis, MN 55454
RE: "Seroquel XR for the Management of Borderline Personality Disorder: A Randomized
Double-Blind Comparison with Placebo
IRB Code Number: 0709M16844
Dear Dr. Schulz:
At its meeting on June 17, 2010 the Institutional Review Board (IRB) reviewed and noted
unanticipated problem and adverse event report for the referenced study. The following reports
were included in this review: AstraZenica Study #IRUSQUET0454, event date: May 17, 2010,
report date: May 27, 2010.
Thank you for keeping the IRB informed of the status of your research.
As Principal Investigator of this project, you are required by federal regulations to inform the
IRB of any proposed changes in your research that will affect human subjects. Changes should
not be initiated until written IRB approval is received. Unanticipated problems and adverse
events should be reported to the IRB as they occur. Research projects are subject to continuing
review and renewal.
If you have any questions, call the IRB office at 612-626-5654.

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*rt--

Andrew Allen
Research Compliance Supervisor
AAIks
CC: Scott Crow, Peter Milev, Michael Miller, Richelle Moen, Ann Romine, John Vuchetich