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 Subjects With Schizophrenia

GlaxoSmithKline1 site in 1 country231 target enrollmentOctober 2002

Overview

A Placebo Controlled Study For Patients With Schizophrenia

Registry

clinicaltrials.gov

Start Date

October 2002

End Date

April 2003

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

•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.

Change from baseline in the PANSS total score.

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.