SB-773812 Administered In Adults With Schizophrenia
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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 study to receive placebo, SB-773812 60mg or olanzapine 15mg for 12 weeks in Part A. An interim analysis will be conducted to assess the efficacy and safety of the SB-773812 60mg dose compared with placebo. Based on these data, up to two further doses of SB-773812 will be added to the randomization for Part B.
A Multi Centre, Double-Blind, Double-Dummy, Placebo-Controlled, Randomised, Adaptive, Dose-Range Study To Evaluate the Safety and Efficacy of SB-773812 Administered Once Daily for 12 Weeks in Adults With Schizophrenia
Study Start Date
Actual Study Completion Date
Resource links provided by the National Library of Medicine
total score for each SB-773812 dose versus placebo at Week 6. [ Time Frame: 12 Weeks ]
Secondary Outcome Measures
Evaluate safety of SB-773812 versus placebo and compared to olanzapine using PANNS scores -Measure the preliminary pharmacokinetic/pharmacodynamic relationships for SB-773812 -Assessment of movement disorders and cognitive functioning [ Time Frame: 12 Weeks ]
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.