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

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

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.
180

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 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

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

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

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.
May 1, 2003

Study Completion

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, 2003

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).
June 25, 2003

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.
June 25, 2003

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.
June 26, 2003

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.
August 28, 2009

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.
August 27, 2009

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.
December 1, 2003

More Information

Terms related to this study

Keywords

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.
  • 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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