Conditions: Schizophrenia
Keywords: Schizophrenia Antipsychotic Zicronapine Lu 31-310
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 46
Healthy volunteers: no

Brief summary:
The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of once weekly dosing of zicronapine, compared to daily dosing of zicronapine.

Detailed description:
The study includes 2 treatment periods. The open-label run-in period will begin at patient enrolment and continue for 3 weeks, during which all patients will receive once daily treatment with zicronapine. The double-blind period will begin at patient randomization and continue for 5 weeks, during which the patients will be assigned to one group receiving once daily treatment with zicronapine and 3 groups receiving once weekly treatment with zicronapine.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: Zicronapine open-label lead-in 10 mg daily intervention 2: Zicronapine 10 mg daily intervention 3: Zicronapine 20 mg once weekly intervention 4: Zicronapine 30 mg once weekly intervention 5: Zicronapine 45 mg once weekly
Intervention descriptions: intervention 1: Encapsulated tablet ,10 mg, once daily, open-label intervention 2: Encapsulated tablet, 10 mg, once daily, double-blind intervention 3: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind intervention 4: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind intervention 5: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Protocol document: