Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia
- Registration Number
- NCT00103727
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study will evaluate whether talnetant (200mg, 400mg, 600mg) twice a day is effective compared to placebo and risperidone 1-3mg twice a day in treating the positive and negative symptoms of schizophrenia. Study subjects will be treated with study drug for up to 6 weeks and will then return for a follow-up visit 2 weeks later. About 275 patients with schizophrenia will be enrolled in this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 282
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description risperidone risperidone 3mg twice a day placebo placebo placebo talnetant Talnetant 200mg, 400mg, 600mg) twice a day
- Primary Outcome Measures
Name Time Method The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values. 6 weeks
- Secondary Outcome Measures
Name Time Method The secondary measures assess both efficacy (cognition, depression) as well as a variety of safety/tolerability endpoints (adverse events, motor function, laboratory measures). 6 weeks
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Richmond, Virginia, United States
GSK Investigational Site🇺🇸Richmond, Virginia, United States