Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00103727
First received: February 14, 2005
Last updated: February 13, 2013
Last verified: February 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014