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Aripiprazole Used as Dual Therapy in the Treatement of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder.

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Quetiapine or Risperidone + Aripiprazole
Quetiapine or Risperidone + placebo
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient with diagnosis of chronic Schizophrenia or Schizoaffective disorder Stable symptoms and dose of Quetiapine or Risperidone Exclusion Criteria: First diagnosis in the past year Significant risk of suicide or meet DSM-IV-TR criteria for substance abuse

Sites / Locations

  • K & S Professional Research Services, Llc
  • Comprehensive Neuroscience, Inc.
  • Atp Clinical Research, Inc.
  • Collaborative Neuroscience Network, Inc.
  • San Fernando Mental Health Center
  • Uci Medical Center
  • California Clinical Trials Medical Group
  • California Clinical Trials
  • Sharp Mesa Vista Hospital
  • California Neuropsychopharmacology Clinical Research Inst.
  • Schuster Medical Research Institute
  • Department Of Psychiatry And Behavioral Sciences
  • Pacific Clinical Research Medical Group
  • University Of Colorado At Denver And Health Sciences Center
  • Institute Of Living
  • Behavioral Clinical Research, Inc
  • Uptown Research Institute, Llc
  • Alexian Center For Psychiatric Research
  • Indiana University School Of Medicine
  • Lsu Health Sciences Center
  • J. Gary Booker, Md
  • Sheppard Pratt Health System
  • North Suffolk Mental Health Association
  • Community Counseling Of Bristol County, Inc. (Ccbc)
  • University Of Minnesota
  • Precise Research Centers
  • Cri Worldwide, Llc
  • Neurobehavioral Research, Inc.
  • Advanced Bio-Behavioral Sciences
  • The Zucker Hillside Hospital
  • New York State Psychiatric Institute
  • Manhattan Psychiatric Center
  • Strong Ties Community Support Program
  • Behavioral Medical Research Of Staten Island
  • Richmond Behavioral Associates
  • Duke University Health System
  • Saroj B. Brar, M.D., Inc.
  • Midwest Clinical Research Center
  • Department Of Veterans Affairs Medical Center
  • Suburban Research Associates
  • Va Medical Center (116a)
  • Thomas Jefferson University
  • Belmont Center For Comprehensive Treatment
  • Cri Worldwide, Llc
  • Vanderbilt University Medical Center
  • Medlabs Research Of Houston, Inc.
  • University Of Texas Health Science Center At San Antonio
  • Va Puget Sound Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Quetiapine or Risperidone + Aripiprazole

Quetiapine or Risperidone + placebo

Arm Description

Outcomes

Primary Outcome Measures

Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Positive and Negative Symptoms Scale (PANSS) score at endpoint

Secondary Outcome Measures

Assess efficacy according to changes in the severity of illness symptoms as measured by the Clinical Global Impressions-Severity (CGI-S)

Full Information

First Posted
May 11, 2006
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00325689
Brief Title
Aripiprazole Used as Dual Therapy in the Treatement of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical

4. Oversight

5. Study Description

Brief Summary
A Multicenter, Double-blind 16 Week Study on the augmentation of atypical antipsychotic with Aripiprazole in patients with Schizophrenia with inadequate response to antipsychotic treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
323 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quetiapine or Risperidone + Aripiprazole
Arm Type
Active Comparator
Arm Title
Quetiapine or Risperidone + placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Quetiapine or Risperidone + Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Aripiprazole 2-15 mg/day, Flexible, 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Quetiapine or Risperidone + placebo
Intervention Description
Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Placebo, Flexible, 16 weeks.
Primary Outcome Measure Information:
Title
Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Positive and Negative Symptoms Scale (PANSS) score at endpoint
Time Frame
(Week 16) or at time of discontinuation
Secondary Outcome Measure Information:
Title
Assess efficacy according to changes in the severity of illness symptoms as measured by the Clinical Global Impressions-Severity (CGI-S)
Time Frame
at endpoint (Week 16)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with diagnosis of chronic Schizophrenia or Schizoaffective disorder Stable symptoms and dose of Quetiapine or Risperidone Exclusion Criteria: First diagnosis in the past year Significant risk of suicide or meet DSM-IV-TR criteria for substance abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
K & S Professional Research Services, Llc
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
Facility Name
Comprehensive Neuroscience, Inc.
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Atp Clinical Research, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Collaborative Neuroscience Network, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
San Fernando Mental Health Center
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Facility Name
Uci Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
California Clinical Trials Medical Group
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
California Clinical Trials
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sharp Mesa Vista Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
California Neuropsychopharmacology Clinical Research Inst.
City
San Diego
State/Province
California
ZIP/Postal Code
92126
Country
United States
Facility Name
Schuster Medical Research Institute
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Department Of Psychiatry And Behavioral Sciences
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
University Of Colorado At Denver And Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Institute Of Living
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Behavioral Clinical Research, Inc
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Uptown Research Institute, Llc
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Alexian Center For Psychiatric Research
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
Facility Name
Indiana University School Of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Lsu Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
J. Gary Booker, Md
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
Sheppard Pratt Health System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21285
Country
United States
Facility Name
North Suffolk Mental Health Association
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Community Counseling Of Bristol County, Inc. (Ccbc)
City
Taunton
State/Province
Massachusetts
ZIP/Postal Code
02780
Country
United States
Facility Name
University Of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Cri Worldwide, Llc
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
Neurobehavioral Research, Inc.
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Advanced Bio-Behavioral Sciences
City
Elmsford
State/Province
New York
ZIP/Postal Code
10523
Country
United States
Facility Name
The Zucker Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Manhattan Psychiatric Center
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Facility Name
Strong Ties Community Support Program
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Behavioral Medical Research Of Staten Island
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Saroj B. Brar, M.D., Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44113
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Department Of Veterans Affairs Medical Center
City
Coatesville
State/Province
Pennsylvania
ZIP/Postal Code
19320
Country
United States
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Va Medical Center (116a)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Belmont Center For Comprehensive Treatment
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
Facility Name
Cri Worldwide, Llc
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19149
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Medlabs Research Of Houston, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77057
Country
United States
Facility Name
University Of Texas Health Science Center At San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Va Puget Sound Health Care System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98493
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19906340
Citation
Kane JM, Correll CU, Goff DC, Kirkpatrick B, Marder SR, Vester-Blokland E, Sun W, Carson WH, Pikalov A, Assuncao-Talbott S. A multicenter, randomized, double-blind, placebo-controlled, 16-week study of adjunctive aripiprazole for schizophrenia or schizoaffective disorder inadequately treated with quetiapine or risperidone monotherapy. J Clin Psychiatry. 2009 Oct;70(10):1348-57. doi: 10.4088/JCP.09m05154yel.
Results Reference
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Aripiprazole Used as Dual Therapy in the Treatement of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder.

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