Effect Of Talnetant Versus Risperidone Versus Placebo On Psychotic Symptoms In Schizophrenic Patients

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Schizophrenia

Treatments

Drug: Talnetant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00300963

223412/093

Details and patient eligibility

About

The purpose of this study is to test the safety and effectiveness of talnetant vs. risperidone vs. placebo in reducing positive and negative symptoms in acutely psychotic schizophrenia patients.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects must have schizophrenia which is not secondary to another medical condition or substance abuse.
Require inpatient hospitalization.
Women may enroll only if they are not of child-bearing potential OR are on a protocol-approved birth control method.

Exclusion criteria

Subject is in their first episode of schizophrenia.
Subject has other psychotic disorders or bipolar disorder.
Subject has schizophrenia symptoms from taking another medicine or drug of abuse, or due to a general medical condition.
Subject has a recent history of substance dependence, or tests positive for illicit drug.
Subject has an unstable medical disorder, or any significant medical disorder including autistic disorder, organic brain disease, liver dysfunction, epilepsy or seizures, or is at increased risk of developing cerebrovascular problems like stroke.
Subject has any significant abnormalities in any of the screening tests (ECGs, labs, physical examinations, etc.).
Subject poses a current serious suicidal or homicidal risk.
Subject has a positive pregnancy test, or is lactating or planning to become pregnant within one month of the study.
Subject has recently or is currently participating in another clinical study.
Subject is stabilized on their current schizophrenia treatment.
Subject needs to take any of the medicines not permitted in the study, or has recently had ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation).
Subject was non-responsive to two or more adequate trials of antipsychotic treatments over the past 2 years.
Subject has had an allergic or significant reaction to any of the study drugs, or can't take risperidone.