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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00063297
First Posted: June 26, 2003
Last Update Posted: August 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  Purpose
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 Intervention Phase
Schizophrenia Drug: R209130 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Estimated Enrollment: 180
Study Start Date: May 2003
Estimated Study Completion Date: October 2003
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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.
  More Information

ClinicalTrials.gov Identifier: NCT00063297     History of Changes
Other Study ID Numbers: CR004342
First Submitted: June 25, 2003
First Posted: June 26, 2003
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
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders