Schizophrenia Study In Adults
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
231
1 country
31
Brief Summary
A Placebo Controlled Study For Patients With Schizophrenia
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 Oct 2002
Shorter than P25 for phase_2 schizophrenia
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
November 15, 2002
CompletedFirst Posted
Study publicly available on registry
November 18, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2003
CompletedAugust 16, 2017
August 1, 2017
6 months
November 15, 2002
August 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the PANSS total score.
Secondary Outcomes (1)
Secondary measures assessed efficacy, safety & tolerability endpoints using the PANSS, BPRS Psychosis score, CGI-S, CGI-GI, Calgary Depression Scale for Schizophrenia, Brief Assessment of Cognition for Schizophrenia, and others.
Interventions
Eligibility Criteria
You may qualify if:
- Patient must meet diagnostic criteria for schizophrenia.
You may not qualify if:
- Patients with other psychotic disorders.
- Patients whose condition is due to the direct physiological effects of a substances (e.g., drug abuse) or a general medical condition.
- Patients with a history of autistic disorder or another pervasive developmental disorder.
- Patients with epilepsy or a history of seizures requiring treatment.
- Patients who are excluded from taking the drug risperidone.
- Patients who pose a current serious suicidal or homicidal risk.
- Patients who are adequately stabilized on their treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (31)
GSK Clinical Trial Call Center
Scottsdale, Arizona, 85251, United States
GSK Clinical Trial Call Center
Cerritos, California, 90703, United States
GSK Clinical Trial Call Center
Chula Vista, California, 91910, United States
GSK Clinical Trial Call Center
Garden Grove, California, 92845, United States
GSK Clinical Trial Call Center
Orange, California, 92868, United States
GSK Clinical Trial Call Center
Pico Rivera, California, 90660, United States
GSK Clinical Trial Call Center
Rosemead, California, 91770, United States
GSK Clinical Trial Call Center
Sacramento, California, 95823, United States
GSK Clinical Trial Call Center
San Diego, California, 92123, United States
GSK Clinical Trial Call Center
San Diego, California, 92126, United States
GSK Clinical Trial Call Center
New Britain, Connecticut, 06050, United States
GSK Clinical Trial Call Center
New Haven, Connecticut, 06519, United States
GSK Clinical Trial Call Center
Washington D.C., District of Columbia, 20016, United States
GSK Clinical Trial Call Center
North Miami, Florida, 33161, United States
GSK Clinical Trial Call Center
Tampa, Florida, 33613, United States
GSK Clinical Trial Call Center
Winter Park, Florida, 32789, United States
GSK Clinical Trial Call Center
Hoffman Estates, Illinois, 60194, United States
GSK Clinical Trial Call Center
Greenwood, Indiana, 46143, United States
GSK Clinical Trial Call Center
Shreveport, Louisiana, 71101, United States
GSK Clinical Trial Call Center
Clementon, New Jersey, 08021, United States
GSK Clinical Trial Call Center
Hollis, New York, 11423, United States
GSK Clinical Trial Call Center
Butner, North Carolina, 27509, United States
GSK Clinical Trial Call Center
Raleigh, North Carolina, 27603, United States
GSK Clinical Trial Call Center
Cincinnati, Ohio, 45267, United States
GSK Clinical Trial Call Center
Cleveland, Ohio, 44109, United States
GSK Clinical Trial Call Center
Norman, Oklahoma, 73069, United States
GSK Clinical Trial Call Center
Oklahoma City, Oklahoma, 73103, United States
GSK Clinical Trial Call Center
Nashville, Tennessee, 37212, United States
GSK Clinical Trial Call Center
Austin, Texas, 78729, United States
GSK Clinical Trial Call Center
Bellaire, Texas, 77401, United States
GSK Clinical Trial Call Center
Terrell, Texas, 75160, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, MD
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 15, 2002
First Posted
November 18, 2002
Study Start
October 1, 2002
Primary Completion
April 1, 2003
Study Completion
April 1, 2003
Last Updated
August 16, 2017
Record last verified: 2017-08