Safety and Efficacy of Aripiprazole in the Long-Term MaintenanceTreatment ofPediatric Subjects with Irritability Associated with Autistic Disorder

Phase 1

Conditions: Irritability in Autism Disorder
Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

Registration Number: EUCTR2017-000174-11-Outside-EU/EEA

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 215

Inclusion Criteria

Male or female subjects 6 to
17 years of age at the time of the baseline visit meeting Diagnostic and
Statistical Manual
of Mental Disorders-Fourth Edition, Text Revision (DSM-IV-TR)
diagnostic criteria for
autistic disorder and demonstrating behaviors such as tantrums,
aggression, self-injurious
behavior, or a combination of these problems were included in the trial.
The diagnosis of
AD was to be confirmed by the Autism Diagnostic Interview-Revised.
Subjects were to
have Clinical Global Impressions-Severity Scale (CGI-S) scores = 4 AND
an ABC-I
Subscale score = 18 at the screening and baseline visits and to have a mental age of at
least 24 months, as assessed by the investigators.
Are the trial subjects under 18? yes
Number of subjects for this age range: 215
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Adult

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective was to evaluate the efficacy of aripiprazole<br>compared<br>with placebo to prevent relapses in pediatric subjects who maintained<br>a response for<br>12 weeks of aripiprazole treatment for their symptoms of irritability<br>associated with<br>autistic disorder as measured by the time from randomization to<br>relapse.;Secondary Objective: To evaluate the long-term effect of aripiprazole on the mean change<br>from end of<br>Phase 1 to endpoint on the Irritability subscale of the Aberrant<br>Behavior<br>Checklist-Irritability Subscale Score (ABC-I)<br>To evaluate the long-term effect of aripiprazole on the mean Clinical<br>Global<br>Impressions-Improvement Scale (CGI-I) Score at endpoint.;Primary end point(s): The primary efficacy endpoint was the time from randomization to<br>relapse.<br>CGI-I and ABC-I were assessed every 2 weeks.;Timepoint(s) of evaluation of this end point: 26 Weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Additional assessments included other<br>ABC subscales and CGI-S. Outcome assessments included PedsQL and<br>CGSQ<br>evaluations.;Timepoint(s) of evaluation of this end point: Week 26