Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)

Registry ID
EUCTR2016-005111-40
Source registry
EUCTR
Phase
PHASE2
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc
Last update
2026-08-16

Conditions

Summary

The primary objective of this trial was to compare the efficacy of flexibly dosed aripiprazole with that of placebo in reducing serious behavioral problems, specifically irritability, agitation, and self-injurious behavior, in children and adolescents with a diagnosis of AD, as measured by change from baseline to endpoint on the Irritability Subscale of the Aberrant Behavior Checklist (ABC).

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