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

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ClinicalTrials.gov Identifier: NCT00063297
Recruitment Status : Completed
First Posted : June 26, 2003
Last Update Posted : August 28, 2009
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: R209130 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : May 2003
Estimated Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00063297

  Show 29 Study Locations
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

ClinicalTrials.gov Identifier: NCT00063297     History of Changes
Other Study ID Numbers: CR004342
First Posted: June 26, 2003    Key Record Dates
Last Update Posted: August 28, 2009
Last Verified: December 2003

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
schizophrenia with negative symptoms

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders