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Effect Of Talnetant Versus Risperidone Versus Placebo On Psychotic Symptoms In Schizophrenic Patients
This study has been completed.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00300963
  Purpose

The purpose of this study is to test the safety and effectiveness of talnetant vs. risperidone vs. placebo in reducing positive and negative symptoms in acutely psychotic schizophrenia patients.


Condition Intervention Phase
Schizophrenia
Drug: Talnetant
Phase II

MedlinePlus related topics: Psychotic Disorders Schizophrenia
Drug Information available for: Risperidone SB 223412
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, 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: December 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.
  • Women 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, 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: NCT00300963

Locations
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72201
United States, California
GSK Investigational Site
Garden Grove, California, United States, 92845
GSK Investigational Site
Oceanside, California, United States, 92056
GSK Investigational Site
Pico Rivera, California, United States, 90660
GSK Investigational Site
Glendale, California, United States, 91206
GSK Investigational Site
Rosemead, California, United States, 91770
GSK Investigational Site
Anaheim, California, United States, 92805
GSK Investigational Site
Cerritos, California, United States, 90703
GSK Investigational Site
Upland, California, United States, 91786
GSK Investigational Site
San Diego, California, United States, 92123
GSK Investigational Site
National City, California, United States, 91950
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
Irving, Texas, United States, 75062
GSK Investigational Site
Austin, Texas, United States, 78756
United States, Virginia
GSK Investigational Site
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: 223412/093
Study First Received: March 7, 2006
Last Updated: October 23, 2008
ClinicalTrials.gov Identifier: NCT00300963  
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
psychosis
cognition

Study placed in the following topic categories:
Schizophrenia
Dopamine
Mental Disorders
Risperidone
Psychotic Disorders
Serotonin
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
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009