Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00103727
First received: February 14, 2005
Last updated: February 13, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Talnetant |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Risperidone
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The secondary measures assess both efficacy (cognition, depression) as well as a variety of safety/tolerability endpoints (adverse events, motor function, laboratory measures). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Study Start Date: | December 2004 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: talnentant |
Drug: Talnetant
talnetant
Other Name: Talnetant
|
|
Placebo Comparator: placebo
placebo
|
Drug: Talnetant
talnetant
Other Name: Talnetant
|
| Active Comparator: risperidone |
Drug: Talnetant
talnetant
Other Name: Talnetant
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103727
Locations
| United States, Arkansas | |
| GSK Investigational Site | |
| Little Rock, Arkansas, United States, 72201 | |
| United States, California | |
| GSK Investigational Site | |
| Anaheim, California, United States, 92805 | |
| GSK Investigational Site | |
| Cerritos, California, United States, 90703 | |
| GSK Investigational Site | |
| Garden Grove, California, United States, 92845 | |
| GSK Investigational Site | |
| Glendale, California, United States, 91206 | |
| GSK Investigational Site | |
| National City, California, United States, 91950 | |
| GSK Investigational Site | |
| Oceanside, California, United States, 92056 | |
| GSK Investigational Site | |
| Pico Rivera, California, United States, 90660 | |
| GSK Investigational Site | |
| Rosemead, California, United States, 91770 | |
| GSK Investigational Site | |
| San Diego, California, United States, 92123 | |
| GSK Investigational Site | |
| Upland, California, United States, 91786 | |
| United States, District of Columbia | |
| GSK Investigational Site | |
| Washington, District of Columbia, United States, 20016 | |
| United States, Florida | |
| GSK Investigational Site | |
| North Miami, Florida, United States, 33161 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Missouri | |
| GSK Investigational Site | |
| St. Louis, Missouri, United States, 63118 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Clementon, New Jersey, United States, 08021 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19131 | |
| United States, Texas | |
| GSK Investigational Site | |
| Austin, Texas, United States, 78756 | |
| GSK Investigational Site | |
| Irving, Texas, United States, 75062 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Richmond, Virginia, United States, 23294 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00103727 History of Changes |
| Other Study ID Numbers: | SB-223412/093 |
| Study First Received: | February 14, 2005 |
| Last Updated: | February 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
catatonic disorganized undifferentiated types paranoid |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 23, 2013