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
Study complete
Study complete
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:
Enrollment:
231
Primary completion date:
2003-30-04
Observational study model:
Not applicable
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
Showing 1 - 6 of 31 Results
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website