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

Tracking Information
First Received Date ^ICMJE	June 25, 2003
Last Updated Date	August 27, 2009
Start Date ^ICMJE	May 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00063297 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia
Official Title ^ICMJE
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Schizophrenia
Intervention ^ICMJE	Drug: R209130
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	180
Completion Date	October 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00063297
Responsible Party
Study ID Numbers ^ICMJE	CR004342
Study Sponsor ^ICMJE	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date	December 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP