Conditions: Schizophrenia
Keywords: schizophrenia Lurasidone Latuda
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 327
Healthy volunteers: no

Brief summary:
Efficacy and Safety study of Lurasidone in pediatric patients.

Detailed description:
To evaluate the efficacy of lurasidone (40 mg/day and 80 mg/day) compared with placebo in adolescent subjects with schizophrenia (diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision \[DSM-IV-TR\] criteria) as measured by the change from Baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6.

Arms:
arm 1: Lurasidone 40 mg once daily arm 2: Lurasidone 80 mg once daily Arm received the Lurasidone 40mg dose first, from Days 1-3, and then received the Lurasidone 80 mg dose from day 4 to Week 6 arm 3: Placebo 40 or 80 mg once daily

Interventions: intervention 1: Lurasidone 40 mg intervention 2: Lurasidone 80 mg intervention 3: Placebo 40 or 80 mg
Intervention descriptions: intervention 1: Lurasidone 40 mg once daily intervention 2: Lurasidone 80 mg once daily intervention 3: Placebo 40 or 80 mg once daily

Protocol document: