Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00103727

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 II

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone SB 223412

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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.

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).

Estimated Enrollment:	275
Study Start Date:	November 2004

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
Gregory Kasczenski, MD
Little Rock, Arkansas, United States, 72211
United States, California
Stephen Mohaupt, MD
Culver City, California, United States, 90232
Raymond Manning, MD
Pico Rivera, California, United States, 90660
David Sack, MD
Cerritos, California, United States, 90703
Carlos Figueroa, MD
Pasadena, California, United States, 91107
Wakelin McNeel, MD
Glendale, California, United States, 91206
Raj Rajani, MD
Anaheim, California, United States, 92805
Mohammed Bari, MD
National City, California, United States, 91950
Jelena Kunovac, MD
Oceanside, California, United States, 92056
Michael Plopper, MD
San Diego, California, United States, 92123
Murray Rosenthal, DO
San Diego, California, United States, 92123
Tram Tran-Johnson, PharmD
San Diego, California, United States, 92126
Dan Zimbroff, MD
Upland, California, United States, 91786
Armen Goenjian, MD
Garden Grove, California, United States, 92845
United States, District of Columbia
Adam Lowy, MD
Washington, District of Columbia, United States, 20016
United States, Florida
Anjali Pathak, MD
Jacksonville, Florida, United States, 32216
Sohail Punjwani, MD
North Miami, Florida, United States, 33161
Scott Segal, MD
North Miami, Florida, United States, 33161
David Flaherty, DO
North Miami, Florida, United States, 33161
United States, Georgia
Robert Riesenberg, MD
Atlanta, Georgia, United States, 30308
United States, Missouri
Rick Mofsen, MD
St. Louis, Missouri, United States, 63118
United States, New Jersey
Stephen Glass, MD
Clementon, New Jersey, United States, 08021
United States, Pennsylvania
Richard Jaffe, MD
Philadelphia, Pennsylvania, United States, 19131
United States, Texas
Mary Ann Knesevich, MD
Irving, Texas, United States, 75062
Matthew Brams, MD
Houston, Texas, United States, 77007
David Brown, MD
Austin, Texas, United States, 78756
United States, Virginia
John Gilliam, DO
Richmond, Virginia, United States, 23229

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Study ID Numbers:	SB-223412/093
Study First Received:	February 14, 2005
Last Updated:	September 26, 2006
ClinicalTrials.gov Identifier:	NCT00103727 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

disorganized
catatonic
paranoid
undifferentiated types

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Risperidone
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Serotonin

Schizophrenia
Dopamine
Mental Disorders
Psychotic Disorders
Dopamine Agents
Catatonia
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Risperidone
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents

Pharmacologic Actions
Schizophrenia
Serotonin Antagonists
Serotonin Agents
Mental Disorders
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009