Schizophrenia Study In Adults

Phase 2

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00049946
• Lead Sponsor: GlaxoSmithKline

Brief Summary

A Placebo Controlled Study For Patients With Schizophrenia

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2002-11-15
• Study First Submitted QC: 2002-11-15
• Study First Posted: 2002-11-18
• Primary Completion: 2003-04
• Study Completion: 2003-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

Inclusion Criteria

• Patient must meet diagnostic criteria for schizophrenia.

Exclusion Criteria

• Patients with other psychotic disorders.
• Patients whose condition is due to the direct physiological effects of a substances (e.g., drug abuse) or a general medical condition.
• Patients with a history of autistic disorder or another pervasive developmental disorder.
• Patients with epilepsy or a history of seizures requiring treatment.
• Patients who are excluded from taking the drug risperidone.
• Patients who pose a current serious suicidal or homicidal risk.
• Patients who are adequately stabilized on their treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in the PANSS total score.

Secondary Outcome Measures

Name	Time	Method
Secondary measures assessed efficacy, safety & tolerability endpoints using the PANSS, BPRS Psychosis score, CGI-S, CGI-GI, Calgary Depression Scale for Schizophrenia, Brief Assessment of Cognition for Schizophrenia, and others.

Trial Locations

Locations (1)

GSK Clinical Trial Call Center; 🇺🇸 Terrell, Texas, United States