Conditions: Autism
Keywords: Autism, Lurasidone, Latuda
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 150
Healthy volunteers: no

Brief summary:
This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent subjects with irritability associated with autistic disorder who reside in the community setting.

Detailed description:
This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent subjects with irritability associated with autistic disorder who reside in the community setting.

Arms:
arm 1: Lurasidone 20 mg once daily arm 2: Lurasidone 60 mg once daily arm 3: Placebo once daily

Interventions: intervention 1: Lurasidone 20 mg daily intervention 2: Lurasidone intervention 3: Placebo
Intervention descriptions: intervention 1: Lurasidone 20 mg once daily intervention 2: Lurasidone 60 mg once daily intervention 3: Placebo

Protocol document: