Conditions: Schizophrenia Cognitive Effect on Schizophrenic Patients
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 269
Healthy volunteers: no

Brief summary:
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).

Detailed description:

Arms:
arm 1: Dose titration 15-35mg/day for 6 months arm 2: Dose titration 2-6mg/day for 6 months

Interventions: intervention 1: CYP-1020 intervention 2: Risperidone
Intervention descriptions: intervention 1: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity. intervention 2: None

Protocol document: