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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
323

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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