CompletedPhase 2

Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia

United States282 participantsStarted 2004-12

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * 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. 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/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 stimu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values.

Timeframe: 6 weeks

Trial details

NCT IDNCT00103727

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-10

View on ClinicalTrials.gov More Schizophrenia trials