Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism

Otsuka Pharmaceutical Co., Ltd.528 enrolled

Overview

The purpose of this study is to evaluate the safety and effectiveness of aripiprazole in patients with autism in the real world clinical setting in Japan.

Study Type

OBSERVATIONAL

Enrollment

528

Conditions

Autism

Interventions

Aripiprazole oral productDRUG

oral administration of aripiprazole

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * diagnosed as autism with irritability Exclusion Criteria: * patients who has ever been treated with aripiprazole

Locations (1)

Otsuka Pharmaceutical Co., Ltd.

Tokyo, Japan

Outcomes

Primary Outcomes

Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline.

Using caregiver-rated ABC-J, the degree of aberrant behaviors was scored on four levels ranging from 0 'not at all a problem', 1 'slight problem', 2 'moderately serious problem' to 3 'the problem is severe in degree' in irritability subscale (including 15 items describing symptoms of irritability, such as temper tantrums, aggression, mood changes, and self-injury). The irritability subscale score ranging from 0 to 45 was derived from the sum of the 15 items and higher values represent a worse outcome.

Time frame: Baseline, Week 4, 8, 16, 24, 52

Data from ClinicalTrials.gov

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