Conditions: Schizophrenia
Keywords: Schizophrenia Lurasidone Latuda
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 412
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in subjects with an acute exacerbation of schizophrenia.

Detailed description:
The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in subjects with an acute exacerbation of schizophrenia. This study will also evaluate the efficacy and safety of lurasidone 80 mg/day and160 mg/day versus placebo in subjects who are early non-responders (operationally defined per protocol) to lurasidone 80 mg/day.

Arms:
arm 1: Lurasidone 20 mg once daily arm 2: Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2 arm 3: Placebo Comparator 20 or 80 mg once daily

Interventions: intervention 1: Lurasidone intervention 2: Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2 intervention 3: Placebo
Intervention descriptions: intervention 1: Lurasidone 20 mg once daily intervention 2: Lurasidone 80 mg once daily intervention 3: Once Daily

Protocol document: