Last updated: 11/04/2018 11:30:57
Schizophrenia Study In Adults
GSK study ID
SB223412/078
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: A Placebo Controlled Study For Patients With Schizophrenia
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: talnetant
Drug: risperidone
Enrollment:
231
Observational study model:
Not applicable
Primary completion date:
2003-30-04
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Schizophrenia
Product
talnetant
Collaborators
Not applicable
Study date(s)
October 2002 to April 2003
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
no
- Patient must meet diagnostic criteria for schizophrenia.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- Patient must meet diagnostic criteria for schizophrenia.
Exclusion criteria:
- 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.
Trial location(s)
Location
GSK Clinical Trial Call Center
Oklahoma City, OK, United States, 73103
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Shreveport, LA, United States, 71101
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Cleveland, OH, United States, 44109
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Austin, TX, United States, 78729
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
New Haven, CT, United States, 06519
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Scottsdale, AZ, United States, 85251
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Clementon, NJ, United States, 08021
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
New Britain, CT, United States, 06050
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Hoffman Estates, IL, United States, 60194
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Bellaire, TX, United States, 77401
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Raleigh, NC, United States, 27603
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Washington, DC, United States, 20016
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Butner, NC, United States, 27509
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Nashville, TN, United States, 37212
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
San Diego, CA, United States, 92123
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Tampa, FL, United States, 33613
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
North Miami, FL, United States, 33161
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Cerritos, CA, United States, 90703
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Norman, OK, United States, 73069
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Terrell, TX, United States, 75160
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Sacramento, CA, United States, 95823
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Rosemead, CA, United States, 91770
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Winter Park, FL, United States, 32789
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Chula Vista, CA, United States, 91910
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Cincinnati, OH, United States, 45267
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Pico Rivera, CA, United States, 90660
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Garden Grove, CA, United States, 92845
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
San Diego, CA, United States, 92126
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Greenwood, IN, United States, 46143
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Holliswood, NY, United States, 11423
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
Orange, CA, United States, 92868
Status
Recruitment Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
2003-30-04
Actual study completion date
2003-30-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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