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

November 7, 2013 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

323

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
(Week 16) or at time of discontinuation

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
at endpoint (Week 16)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Otsuka America Pharmaceutical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

May 11, 2006

First Submitted That Met QC Criteria

May 12, 2006

First Posted (Estimate)

May 15, 2006

Study Record Updates

Last Update Posted (Estimate)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN138-397 ST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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