Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism
Completed
- Conditions
- Autism
- Registration Number
- NCT03179787
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 528
Inclusion Criteria
- diagnosed as autism with irritability
Exclusion Criteria
- patients who has ever been treated with aripiprazole
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Otsuka Pharmaceutical Co., Ltd.
🇯🇵Tokyo, Japan