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

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 2

Conditions

Schizophrenia

Treatments

Drug: R209130

Study type

Interventional

Funder types

Industry

Identifiers

NCT00063297

CR004342

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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