Studies for Adson, Jensen, Olson and Schultz submitted to IRB as of November 2013 per Carl Elliott Data Request Date # of subjects PI IRB# Title F inal Approval date Inac Inacti tive ved d Date Date of of last last IRB IRB appr approv oval al enro enroll lled ed Studies in Question (specifically referenced in original request) c ac ac y a n o e ra ra yo a nz nz ap ap n e, e, u e a p ne ne a n s pe per o ne ne n e Treatment of First Episode Psychosis: A Randomized Double Blind 52-Week 2 Ol 19 Olso son, n, Step Stephe hen n 0202 02 02M1 M174 7441 41 Comparison - The Cafe Study 4/22/2002 8/8/2005 1/26/2005 n p e nn- a e l, le le xi xi l ee- o se se , o ng ng - e rm rm a e y a n i ca ca cy cy u y o Bifeprunox in the Treatment of Schizophrenia, Protocol S1543002 (Extension 3 Ol 3/28/2008 12 Olso son, n, Ste Steph phen en 0309 03 09M5 M526 2653 53 of Protocol S1543001) 3 /1 /1 8/ 8/ 20 20 04 04 8 /2 /2 2 2// 20 20 08 08 l , -l l, l l , ll ll Cataractogenic Potential of Quetiapine Fumarate (SEROQUEL) and Risperdone (RISPERDAL) in the Long-term Treatment of Patients with 4 Ol 8/21/2008 7 Olso son, n, Ste Steph phen en 0310 03 10M5 M531 3142 42 Schizophrenia or Schizoaffective Disorder Protocol 5077IL/0089 2/25 2/ 25/2 /200 004 4 11/1 11 /13/ 3/20 2008 08 Active Studies (5) MOSA MOSAIC IC:: T e Man Manag agem emen entt o Sc zop zop ren ren a n C nca Prac Practt ce: ce: A Prospective, Non-Interventional Registry of Diverse Patients with Schizophrenia Across the Disease Spectrum in Usual Care Settings: Course 5 Olso 8 Olson, n, Step Stephe hen n 1303 1303M2 M293 9344 44 of Disease, Treatments, and Burden of IlL/Ness 3/28/2013 2/7/2014 6 Schulz, S Charles 137 1005M81772 PROTEOMIC DIAGN OSTIC TEST FOR SCHIZOPHREN IA 9/9/2010 2/14/2013 on on gg- e rm rm, u ce n e r, r, p en en - a e u y o v a ua ua e e a e y a n 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 7 Schulz 3 Schulz,, S Charles Charles 1007M8 1007M8581 5814 4 or without Psychotic Features 2/25/2011 10/30/2013 , , , , , 3 Study of 2 Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Receptor Agonist (EVP-6124) or Placebo as an Adjunctive Pro-cognitive Treatment in approved for Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy 20 subjects, 0 8 Schulz Protocol No.: EVP-6124-015 IND #076939 enrolled Schulz,, S Charles Charles 1309M4 1309M4404 4049 9 12/9/2013 12/9/2013 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 9 Schulz Schulz,, S Charles Charles 1309M4 1309M4406 4061 1 Antipsychotic Therapy IND Number: 076939 Inactive Studies (46)
10 Ad so son, D av av id id
9/1/2004
11 Ad so son, D av av id id
A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of the Safety and Efficacy of Aripiprazole as Adjunctive Therapy in the Treatment of 0 50 502 M6 M6 73 730 6 Patients with Major Depr essive Disorder (BMS Protocol CN138165)
3/16/2005
Events/injuries reported to IRB
# of Local events/injuries
# of Local Deaths
In ImageNow L/O
2
1
In ImageNow L/O
2
0
In ImageNow L/O
5
0
2
0
6
0
In ImageNow N In ImageNow N
In ImageNow L/O
In ImageNow N
approved for 20 subjects, 0 enrolled In ImageNow N 1/ 10/2014
1/10/2014
GlaxoSmithKline Protocol WXL100368: A Multi-Center, Randomized, DoubleBlind, 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 0 40 407 M6 M6 24 242 4 Depressive Disor der
File File Statu Statuss
8/12/2005
approved for 400 subjects 8/10/2005 0 enr enrol olle led d In HRPP HRPP
N
8/15/2008
2/14/2008
L/O
65
In HRPP
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Studies for Adson, Jensen, Olson and Schultz submitted to IRB as of November 2013 per Carl Elliott Data Request
12 Ad so son, D av av id id
A Multi-Center, Double-Blind, Randomized-Withdrawal, Randomized-Withdrawal, Parallel-Group, Placebo-Controlled Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) as Monotherapy in the Maintenance Treatment Treatment of Patients with Major Depression Disorder 0 51 512 M7 M7 80 805 2 Following an Open-Label Stabilization Period (AMETHYST STUDY)
13 Ad so son, D av av id id
A Multi-Center, Double-Blind, Randomized, Parallel-Group, PlaceboControlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) as Monotherapy in the Treatment of 0 60 602 M8 M8 23 232 6 Patients with Major Depressive Disorder (OPAL STUDY)
14 Ad so son, D av av id id
15 Ad so son, D av av id id 16 Jensen, Jonathan
17 Jense Jensen, n,Jonathan Jonathan
18 Olso Olson, n, Ste Steph phen en 19 Olso Olson, n, Ste Steph phen en
The Use of Quetiapine in the Treatment of Social Phobia: Effects on Cue 0 60 608 M9 M9 15 152 7 Reactivity in Response to Vir tual Reality Publ ic Speaking E nvir onment A Randomized, Randomized, Double-Blind, Double-Blind, Placebo-controlled Placebo-controlled Parallel-Group, Assessment Assessment of the Efficacy, Safety and Tolerability of CX157 60mg TID in Subjects with Protocol #CX157-200 0 80 808 M4 M4 34 342 1 Major Depressive Disor der Pr 0205M26041 A Compar ative Study of New Medications for Psychosis in Adolescents Implementation Implementation of a New Non-verbal Screening Tool, The Children Color Trauma Test (CCTT), in the Evaluation of PTSD i n Children and Young 0908S7 0908S7138 1381 1 Adolescents. Comparative Effectiveness Effectiveness of Antipsychotic Medications Medications in Patients with Schizophrenia-Clinical Schizophrenia-Clinical Antipsychotic Trials of Intervention Effectiveness Effectiveness - The 0111 0111M1 M127 2742 42 CATIE Study Diagnostic Assessment Assessment Core (DAC) for Studies in Schizophrenia and Related 0206 0206M2 M268 6802 02 Disorders
2/13/2006
8/29/2007
1/16/2006
10
In HRPP
O
5/3/2006
8/10/2007
4/12/2007
17
In HRPP
L/O
10/12/2006
1/7/2008
9/12/2007
Withdrawn by PI 9/13/2002
9/21 9/21/2 /201 010 0
study withdrawn prior to start of 9/15/2008 enrollment 1/2/2007
3/23/2006
10/1 10/10/ 0/20 2013 13 study not begun
1
0
L/O 26 In HRPP approved for 100 subjects 0 enrolled In ImageNow N
1
0
15
0
20 In HRPP 20 subjects requested - 0 e nr nr ol ol le le d I n H RP RP P
N
N
2/11/2002
7/22/2005
11/11/2004
16
In HRPP
L/O
7/31/2002
7/11/2008
7/12/2007
108 9 (per Continuing
In HRPP
N
Trusted by over 1 million members
Try Scribd FREE for 30 days to access over 125 million titles without ads or interruptions! Start Free Trial Cancel Anytime.
Studies for Adson, Jensen, Olson and Schultz submitted to IRB as of November 2013 per Carl Elliott Data Request
25 Olso Olson, n, Ste Steph phen en 26 Olso Olson, n, Ste Steph phen en 27 Olso Olson, n, Ste Steph phen en
28 Olso Olson, n, Ste Steph phen en
29 Olso Olson, n, Ste Steph phen en
30 Olso Olson, n, Ste Steph phen en
31 Olso Olson, n, Ste Steph phen en
32 Olso Olson, n, Ste Steph phen en
A Multicenter, Double-Blind, Randomized, Parallel Group, Active-Controlled Tolerability and Safety Study of MK-3756(SM-13496/Lurasidone) MK-3756(SM-13496/Lurasidone) in Clinically 0603 0603M8 M834 3470 70 Stable Schizophrenia Outpatients Effectiveness of Switching from Injectable Conventional Antipsychotic Antipsychotic 0603 0603M8 M841 4169 69 Medications to Injectable Risperidone(Swi tch or Stay) Effectiveness of Switching From Antipsychotic Antipsychotic Polypharmacy to Monotherapy 0606 0606M8 M873 7346 46 (Stay or Switch Study) A Randomized, Double-Blind Study of Olanzapine Versus Aripiprazole in the 0606 0606M8 M883 8386 86 Tr eatment of Schizophrenia (F 1D-MC-HGLB(a)) A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Placebo-Controlled, 16-Week Study of Aripiprazole Used as Dual Therapy in the Tr eatment of Patients with Chronic Stable Schizophrenia or Schizoaffective Disorder Demonstrating Demonstrating an Inadequate Response to Quetiapine or Risperidone Monotherapy (CN 138397) 0607 0607M9 M901 0126 26 A Randomized, Parallel Group, Multiple Dose, 6-Week Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Asenapine in Elderly Subjects 0608 0608M9 M905 0546 46 with Psychosis (Protocol A 7501021) 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 0609 0609M9 M930 3066 66 Pr oblems (the CAMP study) A Multi-Center, Open-Label, Parallel-Group, Randomized, Flexible Dose Study to Evaluate the Safety and Tolerability of Switching from Existing Atypical Antipsychotics Antipsychotics to Bifeprunox in Subjects with S chizophrenia or Schizoaffective 0610 0610M9 M954 5446 46 Disor der. Pr otocol S1543020 A 24-Week, Multi-Center, Double-Blind, Randomized, Randomized, Parallel-Group, Dose
7/14/2006
1/4/2007
1/3/2007
1
In HRPP
O
7/19/2006
1/15/2010
2/25/2009
2
In HRPP
L
7/19/2006
1/15/2010
N
9/15/2006
4/23/2007
17 In HRPP approved for 12 subjects - 0 4/23/2007 e nr nr ol ol le le d I n H RP RP P
9/21/2006
2/5/2008
7/25/2007
5
In HRPP
N
3/6/2007
8/1/2008
7/30/2008
0
In HRPP
O
11/28/2006
7/14/2011
7/28/2010
8
In HRPP
L
1/23/2007
5/8/2008
10/31/2007
3
In HRPP
O
2/25/2009
1
0
1
0
N
Trusted by over 1 million members
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Studies for Adson, Jensen, Olson and Schultz submitted to IRB as of November 2013 per Carl Elliott Data Request 39 Olso Olson, n, Ste Steph phen en
0809 0809M4 M469 6901 01 Comparison of Optimal Antipsychotic Treatments for Schizophrenia (COATS)
40 Olson, Stephen
0905M65703 Cognitive Remediation in the Schizophr enia Tr ials Network (CRiSTN)
41 Olso Olson, n, Ste Steph phen en
0910 0910M7 M738 3857 57
42 Olso Olson, n, Ste Steph phen en
1004 1004M8 M805 0519 19
43 Olso Olson, n, Ste Steph phen en
1011 1011M9 M932 3235 35
44 Olso Olson, n, Ste Steph phen en
1202 1202M1 M103 0381 81
45 Schulz Schulz,, S Charl Charles es
0104M9 0104M9550 5501 1
46 Schulz Schulz,, S Charl Charles es 47 Schu Schulz lz,, S Char Charle less 48 Schulz, S Charles
0308M5 0308M5166 1663 3 0404 0404M5 M591 9124 24 0407M62321
11/10/2008
8/10/2010
7/1/2009
6/2/2010
A Prospective , Randomized Active-controlled, Active-controlled, Rater-blinded Study of the Prevention of Relapse Comparing Paliperidone Palmitate with Oral Risperidone in Adults with Recently-Diagnosed Recently-Diagnosed Schizophrenia Who Are at High Risk of Relapse Study Number: R092670-SCH-3004 S TIP - 11/12/09 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 Clinical and Biomarker Assessment of Efficacy of Cognitive Remediation in Patients with Schizophrenia or Schizoaffective Disorder Stabilized on Lurasidone 3/24/2011 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 Magnetic Resonance Spectroscopy Assessment of Glutamate in Young Patients with S chizophrenia 8/6/2001 MIND (Mental IlL/Ness and Neuroscience Discovery) Consortium MRI Calibration Study 12/11/2003 MIND MIND (Men (Menta tall IlL/ IlL/Ne Ness ss Neur Neuros osci cien ence ce Disc Discov over ery) y) MRI MRI Cons Consor orti tium um Stud Study y 8/4/ 8/4/20 2004 04 Brain Cor relates of Affect Regulation in BPD 1/3/2005 Using Discriminant Analysis of Neuropsychological Neuropsychological and Structural Brain Measureme Variables in the Diagnostic Classification of Adolescents
1 In HRPP approved for 16 subjects - 0 7/10/2009 e nr nr ol ol le le d I n H RP RP P 9/30/2009
N
N
N
3/9/2010
3/9/2010
0
In HRPP
10/12/2011
10/12/2011
0
In ImageNow N
8/29/2013
1/30/2013
8
In ImageNow L/O
4/8/2013
3/27/2013
1
In ImageNow O
1/31/2006
2/17/2005
24
In HRPP
N
8/7/2008 10/24/2013 6/4/2008
9/9/2004 3/7/2007 7/20/2006
10 82 12
In HRPP In HRPP In HRPP
N N N
1
0
Trusted by over 1 million members
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Studies for Adson, Jensen, Olson and Schultz submitted to IRB as of November 2013 per Carl Elliott Data Request Destroyed Files
56 Ad so son, D av av id id 57 Ad so son, D av av id id 58 Ad so son, D av av id id
59 Ad so son, D av av id id
63 Ad so son, D av av id id
290600/711: A 3-Month, Double-Blind, Placebo-Controlled, Fixed-Dose, Extension Study of Paroxetine CR (12.5mg and 25mg/day) Continuous 0 00 005 M4 M4 97 976 1 Treatment for PMDD Patients Completing Studies 29060/677, 688, or 689 Quetiapine as an Adjunctive Therapy for Persistent Anxiety in Those Receiving 0 01 012 M7 M7 78 786 2 Tr eatment with an SS RI Flexible Dose Comparison of the Safety and E fficacy of Escitalopram and 0 10 102 M8 M8 60 606 1 Placebo in the Treatment of Generalized Anxiety Disorder An Open-Label Extension Study of the Safety and Efficacy of Lu 26-054 i n 0 10 105 M0 M0 00 006 1 Patients with Generalized Anxiety Disorder P rotocol SCT-MD-17 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 0 11 110 M0 M0 97 974 1 SmithKline Beecham Protocol SB-659746-A/002
64 Ad so son, D av av id id
0 20 207 M2 M2 94 944 4
65 Ad so son, D av av id id
9 80 803 M0 M0 01 011 7
66 Ad so son, D av av id id
9 80 807 M0 M0 00 002 5
67 Ad so son, D av av id id
9 90 909 M1 M1 84 840 1
Protocol AK130936: A 6 1/2 Month, Multicenter, Randomized, Randomized, Double-Blind, Placebo-Controlled Placebo-Controlled Comparison of 150-300 mg/day of Extended-Release Extended-Release Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Affective Disorder in Subjects with a History of Seasonal Affective Disorder An Open-Label Evaluation of the Efficacy, Safety and Dosing of Citalopram in Outpatients with Depression An Open-Label Extension of Citalopram T reatment in Outpatients with Depression F1D-US-HGHQ Olanzapine Versus Divalproex in the Treatment of Acute Mania
6 /2 /2 3/ 3/ 20 20 00 00
2 /2 /2 5/ 5/ 20 20 02 02
D
2/16/2001
9/11/2002
D
6/27 6/27/2 /200 001 1
10/3 10/31/ 1/20 2003 03
D
7 /2 /2 0/ 0/ 20 20 01 01
1 0/ 0/ 8/ 8/ 20 20 02 02
D
1 1/ 1/ 29 29 /2 /2 00 00 1
9 /1 /1 1/ 1/ 20 20 02 02
D
8/26 8/26/2 /200 002 2
11/2 11/22/ 2/20 2002 02
D
4 /1 /1 7/ 7/ 19 19 98 98
2 /2 /2 5/ 5/ 19 19 99 99
D
8/13/1998 Closed by PI prior to approval
12/17/1999
D
3/8/2000
D
Trusted by over 1 million members
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Studies for Adson, Jensen, Olson and Schultz submitted to IRB as of November 2013 per Carl Elliott Data Request
77 Ad so son, D av av id id
Merck Protocol 026-00: A Double-Blind, Multicenter, Placebo-Controlled 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 0 21 210 M3 M3 38 382 1 Disor der Protocol AK130926: A Multicenter, Double-Blind, Double-Blind, Randomized, PlaceboControlled Comparison of the Effects on Sexual Functioning of ExtendedRelease Bupropion Hydrochloride (300-450 mg) and Escitalopram (10-20 mg) in Outpatients with Moderate to Severe Major Depression Over An Eight0 21 211 M3 M3 75 750 1 Week Treatment Period Aripiprazole As An Adjunctive Therapy for Persistent Anxiety in Those 0 30 305 M4 M4 80 800 1 Receiving T reatment with An SS RI
78 Ad so son, D av av id id
A Phase II Randomized, 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 0 30 306 M4 M4 94 948 8 Infu Infusi sion on Syst System em for for the the Mana Manage geme ment nt of Majo Majorr Dep Depre ress ssiv ive e Ord Order er (MDD (MDD)) DEFR DEFR - 7/9 7/9/0 /03 3
75 Ad so son, D av av id id
76 Ad so son, D av av id id
79 Ad so son, D av av id id #REF! Jense Jensen, n, Jonath Jonathan an
80 Jense Jensen, n, Jonath Jonathan an
A 7 Month, Multicenter, Double-Blind, Double-Blind, Placebo-Controlled Comparison of 150300 mg/day of Extended-Release 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 0 30 308 M5 M5 15 150 1 Phase The Efficacy and Safety of Risperidone in the Treatment of Adolescents with 0104M9 0104M9434 4341 1 Schizophreni a RIS-USA-231 RIS-USA-234: The Efficacy and Safety of Risperidone in the Treatment of Adolescents Adolescents with Schizophrenia: A Follow Up Trial of RIS-USA-231 RIS-SCH0104M9 0104M9436 4361 1 302 An Double-Blind Randomized Study Comparing Intramuscular Olanzapine Depot with Placebo in the Treatment of Patients with Schizophrenia, Protocol
10/23/2002
3/11/2003
D
1 /2 /2 2/ 2/ 20 20 03 03
7 /2 /2 3/ 3/ 20 20 04 04
D
6/24/2003
12/8/2004
D
9/2/ 9/2/20 2003 03
D
9 /1 /1 7/ 7/ 20 20 03 03
6 /1 /1 1/ 1/ 20 20 04 04
D
8/1/2001
12/13/2004
D
8/1/ 8/1/20 2001 01
10/2 10/22/ 2/20 2004 04
D
