Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia
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
1 other identifier
interventional
282
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 schizophrenia
Started Dec 2004
Shorter than P25 for phase_2 schizophrenia
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 14, 2005
CompletedFirst Posted
Study publicly available on registry
February 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedApril 29, 2015
April 1, 2015
10 months
February 14, 2005
April 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values.
6 weeks
Secondary Outcomes (1)
The secondary measures assess both efficacy (cognition, depression) as well as a variety of safety/tolerability endpoints (adverse events, motor function, laboratory measures).
6 weeks
Study Arms (3)
talnetant
EXPERIMENTAL200mg, 400mg, 600mg) twice a day
placebo
PLACEBO COMPARATORplacebo
risperidone
ACTIVE COMPARATOR3mg twice a day
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (22)
GSK Investigational Site
Little Rock, Arkansas, 72201, United States
GSK Investigational Site
Anaheim, California, 92805, United States
GSK Investigational Site
Cerritos, California, 90703, United States
GSK Investigational Site
Garden Grove, California, 92845, United States
GSK Investigational Site
Glendale, California, 91206, United States
GSK Investigational Site
National City, California, 91950, United States
GSK Investigational Site
Oceanside, California, 92056, United States
GSK Investigational Site
Pico Rivera, California, 90660, United States
GSK Investigational Site
Rosemead, California, 91770, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
San Diego, California, 92126, United States
GSK Investigational Site
Upland, California, 91786, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20016, United States
GSK Investigational Site
North Miami, Florida, 33161, United States
GSK Investigational Site
Atlanta, Georgia, 30308, United States
GSK Investigational Site
Oak Brook, Illinois, 60523, United States
GSK Investigational Site
St Louis, Missouri, 63118, United States
GSK Investigational Site
Clementon, New Jersey, 08021, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19131, United States
GSK Investigational Site
Austin, Texas, 78756, United States
GSK Investigational Site
Irving, Texas, 75062, United States
GSK Investigational Site
Richmond, Virginia, 23294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2005
First Posted
February 15, 2005
Study Start
December 1, 2004
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
April 29, 2015
Record last verified: 2015-04