Conditions: Irritability Associated With Autistic Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 215
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether pediatric participants with irritability associated with autistic disorder who have responded to aripiprazole treatment will experience a relapse significantly later when continuing therapy with aripiprazole than will participants who receive placebo

Detailed description:
Phase 1: Single blind/ Phase 2: Double blind

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Aripiprazole intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets, Oral, 2-15 mg, once daily, 13-42 weeks intervention 2: Tablets, Oral, 0 mg, once daily, 16 weeks

Protocol document: