Study Of An FDA-approved Drug As Additional Therapy In Patients With Schizophrenia

Phase 3

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00086593
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This is a 12-week study for the treatment of chronic persistent symptoms in participants with schizophrenia. Participants on a stable, optimal dose of up to two atypical antipsychotics who fulfill the screening criteria will be randomized to receive either an FDA-approved drug or placebo in addition to the current treatment. Safety will be closely monitored through vital signs, various tests, and blood and urine samples.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2004-07-06
• Study First Submitted QC: 2004-07-07
• Study First Posted: 2004-07-08
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-05
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12.	12 Weeks

Secondary Outcome Measures

Name	Time	Method
- Efficacy - Change from baseline in PANSS positive symptoms at Week 12 - Change from baseline in the Scale for the Assessment of Negative Symptoms (SANS) at Week 12 - Change from baseline in PANSS general psychopathology symptoms at Week 12.	12 Weeks

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Hull, United Kingdom