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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
269
CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
Department of Psychiatry, Sheath VS General Hospital, Sheath KM School of Post Graduate Medicine & Research
Ahmedabad, India
Saoji Tupkari Hospital
Aurangabad, India
Spandana Nursing Home
Bangalore, India
KHM Hospital
Chennai, India
Asha Hospital
Hyderabad, India
Department of Psychiatry, Owaisi Hospital & Research Centre
Cognition
To evaluate the cognitive benefits of treatment with CYP-1020 (formerly known as BL-1020) compared to risperidone after 6 weeks of treatment in patients experiencing acute exacerbation of schizophrenia. Assessed by calculating difference between CYP-1020 and Risperidone on mean change from baseline to Week 6 endpoint on MATRICS Consensus Cognition Battery (MCCB) normative composite score. MCCB is a neuropsychological test battery that comprises 10 measures of 7 different cognitive areas including speed of processing, verbal learning, memory-verbal and non verbal reasoning and problem solving, visual learning, social cognition, attention/vigilance.The study was terminated after the interim analysis. MCBB total score ranges from -50 to 150. Change from Baseline by Visit (LOCF)Higher score means better cognitive functioning.
Time frame: Baseline and 6 weeks
Long Term Cognition
Evaluation of the cognitive benefits of treatment with BL-1020 compared to risperidone after 12 and 24 weeks of treatment
Time frame: 12 and 24 weeks of treatment
Long Term Schizophrenia Treatment
Evaluation of the antipsychotic efficacy of BL-1020 compared to risperidone after 6, 12 and 24 weeks of treatment
Time frame: Baseline and 6, 12 and 24 weeks of treatment
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Hyderabad, India
RK Yadav Memorial Mental Health and De-addiction Hospital
Jaipur, India
Mahendru Psychiatric Centre
Kanpur, India
Dreamland Nursing Home
Kolkata, India
Dayanand Medical College & Hospital
Ludhiana, India
...and 29 more locations