Phase IIb-III Study of BL-1020 Small Molecule for Schizophrenia
Status:
Terminated
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
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).