Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Talnetant
* Other: placebo
* Other: risperidone


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: talnetant<br>200mg, 400mg, 600mg) twice a day | Drug: Talnetant<br>* talnetant<br>|
| Placebo Comparator: placebo<br>placebo | Other: placebo<br>* Placebo Comparator<br>|
| Active Comparator: risperidone<br>3mg twice a day | Other: risperidone<br>* Active Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary measures assess both efficacy (cognition, depression) as well as a variety of safety/tolerability endpoints (adverse events, motor function, laboratory measures). |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paranoid, catatonic, undifferentiated types, disorganized