sae spreadsheet from umn general counsel for olson, schulz, adson, jensen

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 dateDate 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


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


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)


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


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


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 NInactive 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


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




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


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 0608M91527The 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


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


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 0206M26802Diagnostic 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


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 0509M73986A 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


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


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




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 0603M84169Effectiveness 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 0606M87346Effectiveness 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 0606M88386A 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


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


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


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


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


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 0703M04621Validation 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


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


'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


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 0809M46541Metformin in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia 11/11/2008 8/10/2010 9/30/2009 13 In HRPP N



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


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


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


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


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 0104M95501Magnetic 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 0308M51663MIND (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 N48 Schulz, S Charles 0407M62321 Brain Correlates of Affect Regulation in BPD 1/3/2005 6/4/2008 7/20/2006 12 In HRPP N


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 0509M73466An 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 0709M16844Seroquel 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 0710M17921FIRST 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


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 NTOTALS 754 39 1



Destroyed Files


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 0012M77862Quetiapine as an Adjunctive Therapy for Persistent Anxiety in Those Receiving Treatment with an SSRI 2/16/2001 9/11/2002 D

58 Adson, David 0102M86061Flexible 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 0105M00061An 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


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


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 9803M00117An 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 9807M00025An Open-Label Extension of Citalopram Treatment in Outpatients with Depression 8/13/1998 12/17/1999 D

67 Adson, David 9909M18401F1D-US-HGHQ Olanzapine Versus Divalproex in the Treatment of Acute Mania

Closed by PI prior to approval 3/8/2000 D


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


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 9912M30941Olanzapine 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 0311E53927Successful Treatment of Refractory ADHD with Methamphetamine: A Case Series 12/2/2003 4/5/2007 D


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


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




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


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 0305M48001Aripiprazole As An Adjunctive Therapy for Persistent Anxiety in Those Receiving Treatment with An SSRI 6/24/2003 12/8/2004 D


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


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 0104M94341The 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


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 0407M61924An 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 0105M98501Nalmefene in the Treatment of Pathological Gambling. A Placebo Controlled Dose Response 1/22/2002 6/9/2003 D

84 Schulz, S Charles 0306M49703A Double-Blind and Placebo-Controlled Assessment of Depakote ER in Borderline Personality Disorder 10/9/2003 1/6/2006 D

85 Schulz, S Charles 0312M54987Efficacy 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 0312M54988Efficacy 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

sae spreadsheet from umn general counsel for olson, schulz, adson, jensen

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