Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism
1 other identifier
observational
528
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 1, 2017
CompletedFirst Posted
Study publicly available on registry
June 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2020
CompletedResults Posted
Study results publicly available
September 16, 2021
CompletedSeptember 16, 2021
August 1, 2021
3 years
June 1, 2017
August 16, 2021
September 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
oral administration of aripiprazole
Eligibility Criteria
naive patients with aripiprasole
You may qualify if:
- diagnosed as autism with irritability
You may not qualify if:
- patients who has ever been treated with aripiprazole
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Otsuka Pharmaceutical Co., Ltd.
Tokyo, Japan
Related Publications (1)
Sugimoto Y, Yamamura K, Takayama T, Fukuta Y, Aoki K, Mikami K, Tomoda A. Aripiprazole in the real-world treatment for irritability associated with autism spectrum disorder in children and adolescents in Japan: 52-week post-marketing surveillance. BMC Psychiatry. 2021 Apr 22;21(1):204. doi: 10.1186/s12888-021-03201-6.
PMID: 33888067DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
It was an observational study in daily clinical practice without a comparison group. In addition, there were deficiencies in the assessments and variations in the reports and evaluation based on the reporting made by the physicians and caregivers.
Results Point of Contact
- Title
- Section Chief of Pharmacovigilance
- Organization
- Otsuka Pharmaceutical Co., Ltd.
Study Officials
- STUDY DIRECTOR
Pharmacovigilance
Otsuka Pharmaceutical Co., Ltd.
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2017
First Posted
June 7, 2017
Study Start
April 1, 2017
Primary Completion
March 17, 2020
Study Completion
July 6, 2020
Last Updated
September 16, 2021
Results First Posted
September 16, 2021
Record last verified: 2021-08