Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT00103727

Run by

GlaxoSmithKline

People needed

282

Starts

2004-12-01

Expected to finish

2005-10-01

Last updated by the study team

2015-04-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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/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.

Where it is running

• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Anaheim, California, United States
• GSK Investigational Site — Cerritos, California, United States
• GSK Investigational Site — Garden Grove, California, United States
• GSK Investigational Site — Glendale, California, United States
• GSK Investigational Site — National City, California, United States
• GSK Investigational Site — Oceanside, California, United States
• GSK Investigational Site — Pico Rivera, California, United States
• GSK Investigational Site — Rosemead, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Upland, California, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — North Miami, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Oak Brook, Illinois, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Clementon, New Jersey, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — Irving, Texas, United States
• GSK Investigational Site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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