An open-label, multi-center, 6-week, sequential cohort study designed to determine the safety and tolerability of two dose ranges of BL-1020 in hospitalized subjects with chronic schizophrenia or schizo-affective disorder
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
BL-1020 Low Dose
BL 1020 High Dose
Dept. of Psychiatry, Sheba Medical Center
Tel Litwinsky, Israel
Spitalul Clinic de Urgenţǎ Militar Central "Dr Carol Davila",
Bucharest, Str Mircea Vulcǎnescu 18, Romania
To determine the safety and tolerability of two dose ranges (20-40 mg/day, 30-50 mg/day) of BL-1020 tri-mesylate (free base) in subjects with chronic schizophrenia or schizo-affective disorder
Time frame: 6 weeks
To determine the MTD, the optimal dose escalation schedule, and the maximum tolerated maintenance dose
Time frame: 6 weeks
To compare the efficacy of the two dose ranges of BL-1020
Time frame: 6 weeks
To determine the pharmacokinetics of BL-1020 and its metabolites
Time frame: 6 weeks
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