COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00103727
Recruitment Status : Completed
First Posted : February 15, 2005
Last Update Posted : April 29, 2015
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Drug: Talnetant Other: placebo Other: risperidone Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2004
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Arm Intervention/treatment
Experimental: talnetant
200mg, 400mg, 600mg) twice a day
Drug: Talnetant

Placebo Comparator: placebo
Other: placebo
Placebo Comparator

Active Comparator: risperidone
3mg twice a day
Other: risperidone
Active Comparator

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00103727

Layout table for location information
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
San Diego, California, United States, 92126
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, Illinois
GSK Investigational Site
Oak Brook, Illinois, United States, 60523
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
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline
Layout table for additonal information
Responsible Party: GlaxoSmithKline Identifier: NCT00103727    
Other Study ID Numbers: SB-223412/093
First Posted: February 15, 2005    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: April 2015
Keywords provided by GlaxoSmithKline:
undifferentiated types
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents