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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00063297
First received: June 25, 2003
Last updated: August 27, 2009
Last verified: December 2003
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00063297

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

No publications provided

ClinicalTrials.gov Identifier: NCT00063297     History of Changes
Other Study ID Numbers: CR004342
Study First Received: June 25, 2003
Last Updated: August 27, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013