Studies for Adson, Jensen, Olson and Schultz submitted to IRB as of November 2013 per Carl Elliott Data

Request
* L = Local Events/Injuries (highlighted in pink), N=No Events/Injuries; O =Offsite Events/Injuries, D= file destroyed per records retention
PI IRB# Title Final Approval date
Date
Inactived Date of last IRB approval
# of subjects
enrolled File Status
Events/injuries
reported to IRB
# of Local
events/injuries
# of Local
Deaths
Studies in Question (specifically referenced in original request)
2 Olson, Stephen 0202M17441
Efficacy and Tolerability of Olanzapine, Quetiapine and Risperidone in the
Treatment of First Episode Psychosis: A Randomized Double Blind 52-Week
Comparison - The Cafe Study 4/22/2002 8/8/2005 1/26/2005 19 In ImageNow L/O 2 1
3 Olson, Stephen 0309M52653
An Open-Label, Flexible-Dose, Long-Term Safety and Efficacy Study of
Bifeprunox in the Treatment of Schizophrenia, Protocol S1543002 (Extension
of Protocol S1543001) 3/18/2004 8/22/2008 3/28/2008 12 In ImageNow L/O 2 0
4
Olson, Stephen 0310M53142
A Multicenter, Open-label, Flexible-dose, Parallel-group Evaluation of the
Cataractogenic Potential of Quetiapine Fumarate (SEROQUEL) and
Risperdone (RISPERDAL) in the Long-term Treatment of Patients with
Schizophrenia or Schizoaffective Disorder Protocol 5077IL/0089
2/25/2004 11/13/2008
8/21/2008 7 In ImageNow L/O 5
0
Active Studies (5)
5 Olson, Stephen 1303M29344
MOSAIC: The Management of Schizophrenia in Clinical Practice: A
Prospective, Non-Interventional Registry of Diverse Patients with
Schizophrenia Across the Disease Spectrum in Usual Care Settings: Course
of Disease, Treatments, and Burden of IlL/Ness 3/28/2013 2/7/2014 8 In ImageNow N
6 Schulz, S Charles 1005M81772 PROTEOMIC DIAGNOSTIC TEST FOR SCHIZOPHRENIA 9/9/2010 2/14/2013 137 In ImageNow N
7 Schulz, S Charles 1007M85814
A Long-term, Multicenter, Open-Label Study to Evaluate the Safety and
Tolerability of Flexible-Dose Oral Aripiprazole (OPC-14597) as Maintenance
Treatment in Adolescent Patients with Schizophrenia or Child and
Adolescent Patients with Bipolar 1 Disorder, Manic or Mixed Episode with
or without Psychotic Features 2/25/2011 10/30/2013 3 In ImageNow L/O 2 0
8 Schulz, S Charles 1309M44049
A Randomized, Double-blind, Placebo-controlled, Parallel, 26-Week, Phase
3 Study of 2 Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist
(EVP-6124) or Placebo as an Adjunctive Pro-cognitive Treatment in
Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy
Protocol No.: EVP-6124-015 IND #076939 12/9/2013 12/9/2013
approved for
20 subjects, 0
enrolled In ImageNow N
9 Schulz, S Charles 1309M44061
A Multicenter 26-Week Extension Study to Evaluate the Safety and Clinical
Effects of Prolonged Exposure to 1 and 2 mg Doses of EVP-6124, an Alpha-7
Nicotinic Acetylcholine Receptor Agonist, as an Adjunctive Pro-cognitive
Treatment in Subjects with Schizophrenia on Chronic Stable Atypical
Antipsychotic Therapy IND Number: 076939 1/10/2014 1/10/2014
approved for
20 subjects, 0
enrolled In ImageNow N
Inactive Studies (46)
10 Adson, David 0407M62424
GlaxoSmithKline Protocol WXL100368: A Multi-Center, Randomized, Double-
Blind, Parallel-Group, Active Controlled, Escalating Dose Study To Compare
The Full Effects On Sexual Functioning Of Bupropion Hydrochloride Extended
Release (WELLBUTRIN XL, 300-450 Mg/Day) And Extended-Release
Venlafaxine (EFFEXOR XR, 150-225 Mg/Day)In Subjects With Major
Depressive Disorder 9/1/2004 8/12/2005 8/10/2005
approved for
400 subjects -
0 enrolled In HRPP N
11 Adson, David 0502M67306
A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of the
Safety and Efficacy of Aripiprazole as Adjunctive Therapy in the Treatment of
Patients with Major Depressive Disorder (BMS Protocol CN138165) 3/16/2005 8/15/2008 2/14/2008 65 In HRPP L/O 6 0
Studies for Adson, Jensen, Olson and Schultz submitted to IRB as of November 2013 per Carl Elliott Data Request
* L = Local Events/Injuries (highlighted in pink), N=No Events/Injuries; O =Offsite Events/Injuries, D= file destroyed per records retention
12 Adson, David 0512M78052
A Multi-Center, Double-Blind, Randomized-Withdrawal, Parallel-Group,
Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine
Fumarate Sustained Release (SEROQUEL SR) as Monotherapy in the
Maintenance Treatment of Patients with Major Depression Disorder
Following an Open-Label Stabilization Period (AMETHYST STUDY) 2/13/2006 8/29/2007 1/16/2006 10 In HRPP O
13 Adson, David 0602M82326
A Multi-Center, Double-Blind, Randomized, Parallel-Group, Placebo-
Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate
Sustained Release (SEROQUEL SR) as Monotherapy in the Treatment of
Patients with Major Depressive Disorder (OPAL STUDY) 5/3/2006 8/10/2007 4/12/2007 17 In HRPP L/O 1 0
14 Adson, David 0608M91527
The Use of Quetiapine in the Treatment of Social Phobia: Effects on Cue
Reactivity in Response to Virtual Reality Public Speaking Environment 10/12/2006 1/7/2008 9/12/2007 20 In HRPP N
15 Adson, David 0808M43421
A Randomized, Double-Blind, Placebo-controlled Parallel-Group, Assessment
of the Efficacy, Safety and Tolerability of CX157 60mg TID in Subjects with
Major Depressive Disorder Protocol #CX157-200 Withdrawn by PI 9/15/2008
study withdrawn prior to start of
enrollment
20 subjects
requested - 0
enrolled In HRPP N
16 Jensen, Jonathan 0205M26041 A Comparative Study of New Medications for Psychosis in Adolescents 9/13/2002 1/2/2007 3/23/2006 26 In HRPP L/O 1 0
17 Jensen, Jonathan 0908S71381
Implementation of a New Non-verbal Screening Tool, The Children Color
Trauma Test (CCTT), in the Evaluation of PTSD in Children and Young
Adolescents. 9/21/2010 10/10/2013 study not begun
approved for
100 subjects -
0 enrolled In ImageNow N
18 Olson, Stephen 0111M12742
Comparative Effectiveness of Antipsychotic Medications in Patients with
Schizophrenia-Clinical Antipsychotic Trials of Intervention Effectiveness - The
CATIE Study 2/11/2002 7/22/2005 11/11/2004 16 In HRPP L/O 15 0
19 Olson, Stephen 0206M26802
Diagnostic Assessment Core (DAC) for Studies in Schizophrenia and Related
Disorders 7/31/2002 7/11/2008 7/12/2007 108 In HRPP N
20 Olson, Stephen 0309M52650 Protocol HGU-MC-HGLM 12/18/2003 6/28/2006 9/22/2005
9 (per
Continuing
Renewal in
RSPP
database) In HRPP O
21 Olson, Stephen 0309M52651
A Randomized, Double-Blind, Placebo-Controlled and Risperdone-Referenced,
Parallel-Group Efficacy and Safety of Two Fixed Doses of Bifeprunox in the
Treatment of Schizophrenia (Protocol S1543001) 3/18/2004 8/23/2005 1/20/2005 2 In HRPP O
22 Olson, Stephen 0509M73986
A Randomized, Placebo-Controlled, Double-Blind Trial of Asenapine in the
Prevention of Relapse after Long-Term Treatment of Schizophrenia 1/5/2006 11/20/2008 12/26/2007 1 In HRPP O
23 Olson, Stephen 0602M81590
A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial
Comparing the Safety and Efficacy of Asenapine with Olanzapine in Subjects
who Completed Protocol A7501013 (Protocol A7501014) 7/31/2006 1/27/2008 2/7/2007 0 In HRPP O
24 Olson, Stephen 0602M81591
A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial
Comparing the Safety and Efficacy of Asenapine with Olanzapine in Stable
Subjects with Predominant, Persistent Negative Symptoms of Schizophrenia
(Protocol A7501013) 6/29/2006 1/27/2008 2/7/2007 0 In HRPP O
Studies for Adson, Jensen, Olson and Schultz submitted to IRB as of November 2013 per Carl Elliott Data Request
* L = Local Events/Injuries (highlighted in pink), N=No Events/Injuries; O =Offsite Events/Injuries, D= file destroyed per records retention
25 Olson, Stephen 0603M83470
A Multicenter, Double-Blind, Randomized, Parallel Group, Active-Controlled
Tolerability and Safety Study of MK-3756(SM-13496/Lurasidone) in Clinically
Stable Schizophrenia Outpatients 7/14/2006 1/4/2007 1/3/2007 1 In HRPP O
26 Olson, Stephen 0603M84169
Effectiveness of Switching from Injectable Conventional Antipsychotic
Medications to Injectable Risperidone(Switch or Stay) 7/19/2006 1/15/2010 2/25/2009 2 In HRPP L 1 0
27 Olson, Stephen 0606M87346
Effectiveness of Switching From Antipsychotic Polypharmacy to Monotherapy
(Stay or Switch Study) 7/19/2006 1/15/2010 2/25/2009 17 In HRPP N
28 Olson, Stephen 0606M88386
A Randomized, Double-Blind Study of Olanzapine Versus Aripiprazole in the
Treatment of Schizophrenia (F1D-MC-HGLB(a)) 9/15/2006 4/23/2007 4/23/2007
approved for
12 subjects - 0
enrolled In HRPP N
29 Olson, Stephen 0607M90126
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 16-Week
Study of Aripiprazole Used as Dual Therapy in the Treatment of Patients with
Chronic Stable Schizophrenia or Schizoaffective Disorder Demonstrating an
Inadequate Response to Quetiapine or Risperidone Monotherapy (CN
138397) 9/21/2006 2/5/2008 7/25/2007 5 In HRPP N
30 Olson, Stephen 0608M90546
A Randomized, Parallel Group, Multiple Dose, 6-Week Study to Evaluate
Safety, Tolerability, and Pharmacokinetics of Asenapine in Elderly Subjects
with Psychosis (Protocol A 7501021) 3/6/2007 8/1/2008 7/30/2008 0 In HRPP O
31 Olson, Stephen 0609M93066
Clinical Management of Metabolic Problems in Patients with Schizophrenia:
Switching to Aripiprazole versus Continued Treatment with Olanzapine,
Quetiapine, or Risperidone Comparison of Antipsychotics for Metabolic
Problems (the CAMP study) 11/28/2006 7/14/2011 7/28/2010 8 In HRPP L 1 0
32 Olson, Stephen 0610M95446
A Multi-Center, Open-Label, Parallel-Group, Randomized, Flexible Dose Study
to Evaluate the Safety and Tolerability of Switching from Existing Atypical
Antipsychotics to Bifeprunox in Subjects with Schizophrenia or Schizoaffective
Disorder. Protocol S1543020 1/23/2007 5/8/2008 10/31/2007 3 In HRPP O
33 Olson, Stephen 0701M00343
A 24-Week, Multi-Center, Double-Blind, Randomized, Parallel-Group, Dose
Ranging Study of the Efficacy and Safety of Oral Doses of AVE 1625 5, 10, and
30 mg and Placebo on Top of an Established Treatment Regimen of either
Olanzapine, Risperidone or Quetiapine Monotherapy in the Treatment of
Cognitive Impairment in Schizophrenia 3/12/2007 12/4/2009 1/16/2009 15
1 of 2 in HRPP
- 2 of 2
purged on
1/6/2010 O
34 Olson, Stephen 0703M04621
Validation of the Reasons for Antipsychotic Discontinuation/Continuation
Questionnaire (RAD-Q) and Interview (RAD-I) 5/3/2007 3/11/2009 3/26/2008 12 In HRPP N
35 Olson, Stephen 0710M19001
A Multi-Center Randomized, Placebo-Controlled, Double-Blind, Parallel-
Group, Phase IIb Proof of Concept Study with 3 Oral Dose Groups of AZD3480
During 12 Weeks Treatment of Cognitive Deficits in Patients with
Schizophrenia 1/10/2008 11/20/2008 10/29/2008 3 In HRPP O
36 Olson, Stephen 0710M19084
'A Randomized, Multicenter, Double-Blind, Parallel Group Study to Compare
the Effects of the Bifeprunox and Quetiapine on Weight Changes in Stable
Schizphrenia Patients' Protocol S1543021 STIP - 11/7/07 5/12/2008 5/12/2008 0 In HRPP N
37 Olson, Stephen 0809M45541
A Phase 2 6-Week Double Blind, Placebo-Controlled, Multicenter Trial of
Varenicline Tartrate (CP-526,555) For Cognitive Impairment in Subjects With
Schizophrenia. Protocol Number A3051100 DEFR - 9/18/08 3/9/2009 study not begun 0 In HRPP N
38 Olson, Stephen 0809M46541
Metformin in the Treatment of Antipsychotic-Induced Weight Gain in
Schizophrenia 11/11/2008 8/10/2010 9/30/2009 13 In HRPP N
Studies for Adson, Jensen, Olson and Schultz submitted to IRB as of November 2013 per Carl Elliott Data Request
* L = Local Events/Injuries (highlighted in pink), N=No Events/Injuries; O =Offsite Events/Injuries, D= file destroyed per records retention
39 Olson, Stephen 0809M46901 Comparison of Optimal Antipsychotic Treatments for Schizophrenia (COATS) 11/10/2008 8/10/2010 9/30/2009 1 In HRPP N
40 Olson, Stephen 0905M65703 Cognitive Remediation in the Schizophrenia Trials Network (CRiSTN) 7/1/2009 6/2/2010 7/10/2009
approved for
16 subjects - 0
enrolled In HRPP N
41 Olson, Stephen 0910M73857
A Prospective , Randomized Active-controlled, Rater-blinded Study of the
Prevention of Relapse Comparing Paliperidone Palmitate with Oral
Risperidone in Adults with Recently-Diagnosed Schizophrenia Who Are at
High Risk of Relapse Study Number: R092670-SCH-3004 STIP - 11/12/09 3/9/2010 3/9/2010 0 In HRPP N
42 Olson, Stephen 1004M80519
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2
Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive
Deficits in Schizophrenia (CDS) 7/6/2010 10/12/2011 10/12/2011 0 In ImageNow N
43 Olson, Stephen 1011M93235
Clinical and Biomarker Assessment of Efficacy of Cognitive Remediation in
Patients with Schizophrenia or Schizoaffective Disorder Stabilized on
Lurasidone 3/24/2011 8/29/2013 1/30/2013 8 In ImageNow L/O 1 0
44 Olson, Stephen 1202M10381
A Multicenter, Open-label Study to Assess Hospitalization Rates in Adult
Subjects with Schizophrenia Treated Prospectively for 6 Months with
Aripiprazole IM Depot Compared with 6-month Retrospective Treatment with
Oral Antipschotics in a Naturalistic Community Setting in North America
(ARRIVE). 7/23/2012 4/8/2013 3/27/2013 1 In ImageNow O
45 Schulz, S Charles 0104M95501
Magnetic Resonance Spectroscopy Assessment of Glutamate in Young
Patients with Schizophrenia 8/6/2001 1/31/2006 2/17/2005 24 In HRPP N
46 Schulz, S Charles 0308M51663
MIND (Mental IlL/Ness and Neuroscience Discovery) Consortium MRI
Calibration Study 12/11/2003 8/7/2008 9/9/2004 10 In HRPP N
47 Schulz, S Charles 0404M59124 MIND (Mental IlL/Ness Neuroscience Discovery) MRI Consortium Study 8/4/2004 10/24/2013 3/7/2007 82 In HRPP N
48 Schulz, S Charles 0407M62321 Brain Correlates of Affect Regulation in BPD 1/3/2005 6/4/2008 7/20/2006 12 In HRPP N
49 Schulz, S Charles 0410M64786
Using Discriminant Analysis of Neuropsychological and Structural Brain
Measurements as Variables in the Diagnostic Classification of Adolescents
with Schizophrenia of Affective Disorders 3/10/2005 2/14/2008 2/15/2007 0 In HRPP N
50 Schulz, S Charles 0506M70791 Brain Correlates of Olanzapine Treatment Response in BPD 11/4/2005 5/26/2009 5/6/2009 29 In HRPP N
51 Schulz, S Charles 0509M73466
An Open-Label Study to Evaluate the Safety of Depakote ER in the Treatment
of Mania Associated with Bipolar I Disorder in Children and Adolescents 1/10/2006 11/2/2006 11/1/2006 2 In HRPP N
52 Schulz, S Charles 0709M16844
Seroquel XR for the Management of Borderline Personality Disorder: A
Randomized Double-Blind Comparison with Placebo 6/5/2008 10/9/2013 10/31/2012 55 In ImageNow L 2 0
53 Schulz, S Charles 0710M17921
FIRST Project: A Diagnostic Clinic for Individuals in the Early Stages of
Schizophrenia 3/24/2008 12/28/2009 4/29/2009 0 In HRPP N
54 Schulz, S Charles 1110M05784
Novartis, Protocol CIL0522D2402, A multicenter, open-label, sequential-
cohort, dose-escalation, 124-day study to explore the tolerability and
pharmacokinetics of iloperidone (Fanapt) 12 to 24 mg/day followed by 26
weeks of flexible dosing (6 to 24 mg/day) in adolesent patients (aged 12 to 17
years)
Closed by PI prior to
approval 6/21/2012 study not begun
0 subjects
enrolled In ImageNow N
55 Schulz, S Charles 1301E26845 A Pilot Study of Best Practices Using Imaging in New-Onset Psychosis 1/24/2013 1/24/2013 1/24/2013
approved for
300 records- 0
enrolled In ImageNow N
TOTALS 754 39 1
Studies for Adson, Jensen, Olson and Schultz submitted to IRB as of November 2013 per Carl Elliott Data Request
* L = Local Events/Injuries (highlighted in pink), N=No Events/Injuries; O =Offsite Events/Injuries, D= file destroyed per records retention
Destroyed Files
56 Adson, David 0005M49761
290600/711: A 3-Month, Double-Blind, Placebo-Controlled, Fixed-Dose,
Extension Study of Paroxetine CR (12.5mg and 25mg/day) Continuous
Treatment for PMDD Patients Completing Studies 29060/677, 688, or 689 6/23/2000 2/25/2002 D
57 Adson, David 0012M77862
Quetiapine as an Adjunctive Therapy for Persistent Anxiety in Those Receiving
Treatment with an SSRI 2/16/2001 9/11/2002 D
58 Adson, David 0102M86061
Flexible Dose Comparison of the Safety and Efficacy of Escitalopram and
Placebo in the Treatment of Generalized Anxiety Disorder 6/27/2001 10/31/2003 D
59 Adson, David 0105M00061
An Open-Label Extension Study of the Safety and Efficacy of Lu 26-054 in
Patients with Generalized Anxiety Disorder Protocol SCT-MD-17 7/20/2001 10/8/2002 D
63 Adson, David 0110M09741
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study
Evaluating Efficacy and Safety of Three Doses of SB-6597466-A (5 mg, 10 mg,
and 20 mg) Versus Placebo in Patients with Major Depressive Disorder
SmithKline Beecham Protocol SB-659746-A/002 11/29/2001 9/11/2002 D
64 Adson, David 0207M29444
Protocol AK130936: A 6 1/2 Month, Multicenter, Randomized, Double-Blind,
Placebo-Controlled Comparison of 150-300 mg/day of Extended-Release
Bupropion Hydrochloride and Placebo for the Prevention of Seasonal
Affective Disorder in Subjects with a History of Seasonal Affective Disorder 8/26/2002 11/22/2002 D
65 Adson, David 9803M00117
An Open-Label Evaluation of the Efficacy, Safety and Dosing of Citalopram in
Outpatients with Depression 4/17/1998 2/25/1999 D
66 Adson, David 9807M00025
An Open-Label Extension of Citalopram Treatment in Outpatients with
Depression 8/13/1998 12/17/1999 D
67 Adson, David 9909M18401
F1D-US-HGHQ Olanzapine Versus Divalproex in the Treatment of Acute
Mania
Closed by PI prior to
approval 3/8/2000 D
68 Adson, David 9909M19381
29060/677 A Double-Blind, Placebo-Controlled, 3-Arm Fixed Dose Study of
Paroxetine CR Continuous Treatment (12.5 mg and 25 mg/day) for
Premenstrual Dysphoric Disorder Including Amendment One 10/26/2000 2/25/2002 D
69 Adson, David 9911M24223
A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Three
Fixed Doses of Aripiprazole in the Treatment of Patients with Acute
Schizophrenia (Protocol CN138-001) 12/15/1999 9/14/2000 D
70 Adson, David 9912M30941
Olanzapine Plus Fluoxetine Combination Therapy in Treatment-Resistant
Depression: A Dose Ranging Study 12/14/2000 5/20/2002 D
71 Jensen, Jonathan 9602M10800 A Clinical Study of Prenatal Exposure to Alcohol 1/22/1997 3/16/2001 D
72 Jensen, Jonathan 0311E53927
Successful Treatment of Refractory ADHD with Methamphetamine: A Case
Series 12/2/2003 4/5/2007 D
73 Olson, Stephen 0102M82681
A Randomized, Open-Label, Rater-Blinded Assessment of Optimal Treatment
Change Strategy to Risperidone for Patients Intolerant of Olanzapine
(Risperidone Rescue Study) Janssen Pharmaceutica Protocol RIS-USA-250 3/20/2001 5/22/2002 D
74 Olson, Stephen 0102M82701
A Multicenter, Double-blind, Randomized Comparison of the Efficacy and
Safety of Sustained-release Formulation Quetiapine Fumarate (Seroquel TM)
and Placebo in the Treatment of Patients with Schizophrenia AstraZeneca
Protocol 5077IL/0041 4/9/2001 12/27/2002 D
Studies for Adson, Jensen, Olson and Schultz submitted to IRB as of November 2013 per Carl Elliott Data Request
* L = Local Events/Injuries (highlighted in pink), N=No Events/Injuries; O =Offsite Events/Injuries, D= file destroyed per records retention
75 Adson, David 0210M33821
Merck Protocol 026-00: A Double-Blind, Multicenter, Placebo-Controlled
Study of L-830982 Gel Extrusion Module (GEM) 1.5 mg Bid to 4.5 mg Bid
Versus Lorazepam in the Treatment of Outpatiens with Generalized Anxiety
Disorder 10/23/2002 3/11/2003 D
76 Adson, David 0211M37501
Protocol AK130926: A Multicenter, Double-Blind, Randomized, Placebo-
Controlled Comparison of the Effects on Sexual Functioning of Extended-
Release Bupropion Hydrochloride (300-450 mg) and Escitalopram (10-20 mg)
in Outpatients with Moderate to Severe Major Depression Over An Eight-
Week Treatment Period 1/22/2003 7/23/2004 D
77 Adson, David 0305M48001
Aripiprazole As An Adjunctive Therapy for Persistent Anxiety in Those
Receiving Treatment with An SSRI 6/24/2003 12/8/2004 D
78 Adson, David 0306M49488
A Phase II Randomized, Blinded Study to Investigate the Safety, Efficacy, and
Tolerability of Thyrotropin-Releasing Hormone (TRH Intrathecal)
Administered by Intrathecal Bolus Injection and via an Implanted SynchroMed
Infusion System for the Management of Major Depressive Order (MDD) DEFR - 7/9/03 9/2/2003 D
79 Adson, David 0308M51501
A 7 Month, Multicenter, Double-Blind, Placebo-Controlled Comparison of 150-
300 mg/day of Extended-Release Bupropion Hydrochloride and Placebo for
the Prevention of Seasonal Depressive Episodes in Subjects with a History of
Seasonal Affective Disorder Followed by an 8-week Observational Follow-up
Phase 9/17/2003 6/11/2004 D
#REF! Jensen, Jonathan 0104M94341
The Efficacy and Safety of Risperidone in the Treatment of Adolescents with
Schizophrenia RIS-USA-231 8/1/2001 12/13/2004 D
80 Jensen, Jonathan 0104M94361
RIS-USA-234: The Efficacy and Safety of Risperidone in the Treatment of
Adolescents with Schizophrenia: A Follow Up Trial of RIS-USA-231 RIS-SCH-
302 8/1/2001 10/22/2004 D
81 Olson, Stephen 0407M61923
An Double-Blind Randomized Study Comparing Intramuscular Olanzapine
Depot with Placebo in the Treatment of Patients with Schizophrenia, Protocol
F1D-MC-HGJZ(b) 9/21/2004 7/11/2005 D
82 Olson, Stephen 0407M61924
An Open-Label Study of Intramuscular Olanzapine Depot in Patients with
Schizophrenia or Schizoaffective Disorder, Protocol F1D-MC-HGKB(b) 9/21/2004 7/11/2005 D
83 Schulz, S Charles 0105M98501
Nalmefene in the Treatment of Pathological Gambling. A Placebo Controlled
Dose Response 1/22/2002 6/9/2003 D
84 Schulz, S Charles 0306M49703
A Double-Blind and Placebo-Controlled Assessment of Depakote ER in
Borderline Personality Disorder 10/9/2003 1/6/2006 D
85 Schulz, S Charles 0312M54987
Efficacy and Safety of Olanzapine in Patients with Borderline Personality
Disorder: A Randomized Double-Blind Comparison with Placebo 2/18/2004 12/21/2005 D
86 Schulz, S Charles 0312M54988
Efficacy and Safety of Olanzapine in Patients with Borderline Personality
Disorder: A Randomized Flexible Dose Double-Blind Comparison with Placebo 3/1/2004 12/21/2005 D
* L = Local Events/Injuries (highlighted in pink), N=No Events/Injuries; O =Offsite Events/Injuries, D= file destroyed per records retention schedule

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