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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00063297
Enrollment
180
Registered
2003-06-26
Start date
2003-05-31
Completion date
2003-10-31
Last updated
2009-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

schizophrenia with negative symptoms

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.

Interventions

DRUGR209130

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026