Status:
COMPLETED
SB-773812 Administered In Adults With Schizophrenia
Lead Sponsor:
GlaxoSmithKline
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a two part study designed to evaluate the safety and efficacy of SB-773812 in the treatment of acute schizophrenia. Subjects with acute schizophrenia will be randomized in an adaptive design s...
Eligibility Criteria
Inclusion
- Meets the diagnostic criteria for schizophrenia as defined in DSM-IV.
- PANSS total score of at least 70 at Screen and Baseline and a minimum score of 4 (moderate) on at least 2 of the following: conceptual disorganization (P2) hallucinatory behaviour (P3) suspiciousness (P6) or unusual thought content (G9) at the Screen and Baseline visits
Exclusion
- Subjects with a history of epilepsy or other seizure disorder, first episode of schizophrenia or other psychotic disorders (e.g. residual type schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, etc.)
- Bipolar disorder, a history of substance dependence, or a medical or psychiatric disorder that would interfere with the accurate assessment of safety or efficacy are not eligible.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
338 Patients enrolled
Trial Details
Trial ID
NCT00259870
Start Date
September 1 2005
End Date
August 1 2007
Last Update
March 23 2017
Active Locations (45)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35233
2
GSK Investigational Site
Cerritos, California, United States, 90703
3
GSK Investigational Site
Garden Grove, California, United States, 92845
4
GSK Investigational Site
National City, California, United States, 91950