Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia

August 27, 2009 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
This study is to determine the efficacy (how well the drug works), safety, and side effects of the study medication compared to placebo in the treatment of the negative symptoms of schizophrenia in adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

180

Phase

  • Phase 2

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
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Birmingham Psychiatry Pharmaceutical Studies, Inc.
    • California
      • Cerritos, California, United States, 90703
        • IPR
      • Chula Vista, California, United States, 91910
        • Synergy Clinical Research
      • La Mesa, California, United States, 91942
        • Optimum Health Services
      • Sacramento, California, United States, 95823
        • Sierra Vista Hospital
      • Santa Ana, California, United States, 92705
        • Clinical Innovations
      • Torrance, California, United States, 90503
        • Research Strategies
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado
    • District of Columbia
      • Washington, DC, District of Columbia, United States, 20016
        • Psychiatric Institute of Washington
    • Florida
      • Hialeah, Florida, United States, 33016
        • Berma Research Group
      • North Miami, Florida, United States, 33161
        • Segal Institute for Clinical Research
      • Pompano Beach, Florida, United States, 33064
        • Quantum Laboratories
    • Georgia
      • Atlanta, Georgia, United States, 30340
        • Med Psych Specialists, LLC
    • Illinois
      • Hoffman Estates, Illinois, United States, 60194
        • Alexian Brothers Behavioral Health Hospital
      • Oakbrook Terrace, Illinois, United States, 60181
        • Midwest Center for Neurobehavioral Medicine
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center-Dept. of Psychiatry
    • New Jersey
      • Clementon, New Jersey, United States, 14760
        • Cns Research Institute
    • New York
      • Lawrence, New York, United States, 11559
        • Neurobehavioral Research
      • Olean, New York, United States, 14760
        • Global Research & Consulting
      • Staten Island, New York, United States, 10304
        • Bayley Seton Campus-Psychiatric Research Division
      • Staten Island, New York, United States, 10305
        • Behavioral Medical Research of Staten Island, P.C.
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Northcoast Clinical Trials
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center
    • Texas
      • Austin, Texas, United States, 78756
        • Community Clinical Research
      • Houston, Texas, United States, 77057
        • MedLabs Research of Houston
      • Irving, Texas, United States, 75062
        • University Hills Clinical Research
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53295
        • Milwaukee VA Medical Center

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

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • Adults aged 18-60
  • Current diagnosis of schizophrenia
  • Significant negative symptoms with few positive symptoms (e.g. hallucinations, delusions) and no evidence of major depression.
  • Female subjects of childbearing potential must test negative for pregnancy at the time of enrollment.
  • Subjects must be able to provide consent
  • Must be healthy based on medical exam, laboratory tests and electrocardiogram

Exclusion:

  • Female subjects who are either pregnant or nursing.
  • Acute or unstable medical conditions
  • Diseases of the central nervous system
  • Subjects who are judged clinically to be at serious risk for suicide or violence
  • Subjects with delusional disorder, psychotic disorder NOS, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder, major depressive disorder,alcohol or drug dependence

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

Collaborators and Investigators

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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

May 1, 2003

Study Completion

October 1, 2003

Study Registration Dates

First Submitted

June 25, 2003

First Submitted That Met QC Criteria

June 25, 2003

First Posted (Estimate)

June 26, 2003

Study Record Updates

Last Update Posted (Estimate)

August 28, 2009

Last Update Submitted That Met QC Criteria

August 27, 2009

Last Verified

December 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR004342

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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