Schizophrenia Clinical Trial
Official title:
A Randomized, Double-Blind, Active-Controlled,Phase 2/3 Study to Determine the Short-Term (6-Week) and Long-Term (6 Month) Cognitive and Anti-Psychotic Efficacy, Safety and Tolerability of CYP-1020 Compared to Risperidone in Patients With Schizophrenia
This is a randomized, double-blind, active-controlled, 6 month study designed to evaluate
the cognitive effects of treatment with CYP-1020 compared to risperidone. The primary
efficacy endpoint will occur after 6 weeks of treatment; additional (secondary) efficacy
endpoints will occur after 12 and 24 weeks of treatment.
Up to 450 patients will be randomized to CYP-1020 or risperidone in a 1:1 ratio. The study
will utilize a flexible dose escalation scheme designed to allow patients to titrate to
their maximally tolerated dose; doses of CYP-1020 may range from a minimum of 15 mg to a
maximum of 35 mg, whereas doses of risperidone will range from a minimum of 1 mg to 3 mg BID
(2-6 mg daily). To ensure effective blinding across all treatment groups, all patients will
be treated twice daily with study drug and/or placebo, as indicated (i.e., double-dummy
design).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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