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

This study has been completed.

First Received on June 25, 2003. Last Updated on August 27, 2009 History of Changes

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00063297

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 II

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 February 12, 2012