Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Autistic Disorder

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, tolerability and the steady-state plasma trough concentration of aripiprazole flexible-dosed in children and adolescents with a diagnosis of Autistic Disorder. Approximately 100 subjects will be randomly assigned at a 1:1 ratio to receive aripiprazole (2 to 15 mg) or placebo treatment for 8 weeks

Timeline

Start

2018-04-09

Primary completion

2020-04-21

Completion

2020-04-21

Drugs

Indications