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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham Psychiatry Pharmaceutical Studies, Inc., Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

R209130

Drug

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Industry

Registry information

Important dates

Study start: 2003
Study completion: 2003
First posted: Jun 26, 2003
Registry last updated: Aug 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed