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

This study has been completed.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00325689
First received: May 11, 2006
Last updated: November 7, 2013
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: Quetiapine or Risperidone + Aripiprazole
Drug: Quetiapine or Risperidone + placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 323
Study Start Date: July 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Quetiapine or Risperidone + Aripiprazole Drug: Quetiapine or Risperidone + Aripiprazole
Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Aripiprazole 2-15 mg/day, Flexible, 16 weeks.
Other Name: Abilify
Placebo Comparator: Quetiapine or Risperidone + placebo Drug: Quetiapine or Risperidone + placebo
Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Placebo, Flexible, 16 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325689

  Hide Study Locations
Locations
United States, Arkansas
K & S Professional Research Services, Llc
Little Rock, Arkansas, United States, 72201
United States, California
Comprehensive Neuroscience, Inc.
Cerritos, California, United States, 90703
Atp Clinical Research, Inc.
Costa Mesa, California, United States, 92626
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States, 92845
San Fernando Mental Health Center
Granada Hills, California, United States, 91344
Uci Medical Center
Orange, California, United States, 92868
California Clinical Trials Medical Group
Paramount, California, United States, 90723
California Neuropsychopharmacology Clinical Research Inst.
San Diego, California, United States, 92126
California Clinical Trials
San Diego, California, United States, 92123
Sharp Mesa Vista Hospital
San Diego, California, United States, 92123
Schuster Medical Research Institute
Sherman Oaks, California, United States, 91403
Department Of Psychiatry And Behavioral Sciences
Stanford, California, United States, 94305
Pacific Clinical Research Medical Group
Upland, California, United States, 91786
United States, Colorado
University Of Colorado At Denver And Health Sciences Center
Denver, Colorado, United States, 80220
United States, Connecticut
Institute Of Living
Hartford, Connecticut, United States, 06106
United States, Florida
Behavioral Clinical Research, Inc
North Miami, Florida, United States, 33161
United States, Illinois
Uptown Research Institute, Llc
Chicago, Illinois, United States, 60640
Alexian Center For Psychiatric Research
Hoffman Estates, Illinois, United States, 60194
United States, Indiana
Indiana University School Of Medicine
Indianapolis, Indiana, United States, 46202
United States, Louisiana
J. Gary Booker, Md
Shreveport, Louisiana, United States, 71104
Lsu Health Sciences Center
Shreveport, Louisiana, United States, 71103
United States, Maryland
Sheppard Pratt Health System
Baltimore, Maryland, United States, 21285
United States, Massachusetts
North Suffolk Mental Health Association
Boston, Massachusetts, United States, 02114
Community Counseling Of Bristol County, Inc. (Ccbc)
Taunton, Massachusetts, United States, 02780
United States, Minnesota
University Of Minnesota
Minneapolis, Minnesota, United States, 55454
United States, Mississippi
Precise Research Centers
Flowood, Mississippi, United States, 39232
United States, New Jersey
Cri Worldwide, Llc
Clementon, New Jersey, United States, 08021
United States, New York
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States, 11516
Advanced Bio-Behavioral Sciences
Elmsford, New York, United States, 10523
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Manhattan Psychiatric Center
New York, New York, United States, 10035
New York State Psychiatric Institute
New York, New York, United States, 10032
Strong Ties Community Support Program
Rochester, New York, United States, 14623
Behavioral Medical Research Of Staten Island
Staten Island, New York, United States, 10305
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
United States, Ohio
Saroj B. Brar, M.D., Inc.
Cleveland, Ohio, United States, 44113
Midwest Clinical Research Center
Dayton, Ohio, United States, 45408
United States, Pennsylvania
Department Of Veterans Affairs Medical Center
Coatesville, Pennsylvania, United States, 19320
Suburban Research Associates
Media, Pennsylvania, United States, 19063
Belmont Center For Comprehensive Treatment
Philadelphia, Pennsylvania, United States, 19131
Va Medical Center (116a)
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Cri Worldwide, Llc
Philadelphia, Pennsylvania, United States, 19149
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
United States, Texas
Medlabs Research Of Houston, Inc.
Houston, Texas, United States, 77057
University Of Texas Health Science Center At San Antonio
San Antonio, Texas, United States, 78229
United States, Washington
Va Puget Sound Health Care System
Tacoma, Washington, United States, 98493
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00325689     History of Changes
Other Study ID Numbers: CN138-397 ST
Study First Received: May 11, 2006
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Quetiapine
Aripiprazole
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 28, 2014