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NCT03179787 Clinical Trial

Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism

Autism Clinical Trial

Official title:
Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03179787
Other study ID # 031-101-00116
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2017
Est. completion date July 6, 2020

Study information
Verified date August 2021
Source Otsuka Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 528
Est. completion date July 6, 2020
Est. primary completion date March 17, 2020
Accepts healthy volunteers No
Gender All
Age group 6 Years to 17 Years
Eligibility Inclusion Criteria: - diagnosed as autism with irritability Exclusion Criteria: - patients who has ever been treated with aripiprazole

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Aripiprazole oral product
oral administration of aripiprazole

Locations
Country Name City State
Japan Otsuka Pharmaceutical Co., Ltd. Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.		 Baseline, Week 4, 8, 16, 24, 52
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