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OpenTrials
Completed

NCT Number: NCT03179787

Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism

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.

Completed

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Otsuka Pharmaceutical Co., Ltd.

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed as autism with irritability

Exclusion criteria

  • patients who has ever been treated with aripiprazole

Treatment and study plan

Aripiprazole oral product

Drug

oral administration of aripiprazole

Primary outcomes

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

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

    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.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 7, 2017
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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