Clinical Trial: Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Double-Blind, Double-Dummy, Placebo-Controlled, Randomized, Parallel Group Evaluation of the Efficacy and Safety of a Fixed-Dose of Talnetant Versus Placebo Versus Risperidone in Subjec

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 Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values. [ Time Frame: 6 weeks ]

Original Primary Outcome:

Current Secondary Outcome: The secondary measures assess both efficacy (cognition, depression) as well as a variety of safety/tolerability endpoints (adverse events, motor function, laboratory measures). [ Time Frame: 6 weeks ]

Original Secondary Outcome:

Information By: GlaxoSmithKline

Dates:
Date Received: February 14, 2005
Date Started: December 2004
Date Completion:
Last Updated: April 27, 2015
Last Verified: April 2015