Autism
Conditions
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.
Interventions
oral administration of aripiprazole
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed as autism with irritability
Exclusion criteria
* patients who has ever been treated with aripiprazole
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Japan
Participant flow
Recruitment details
This surveillance was conducted in 528 participants from 100 trial sites in Japan.
Pre-assignment details
Patients newly treated with aripiprazole for irritability associated with autism spectrum disorder (ASD) in children and adolescents (≥6 years and \<18 years) were included.
Participants by arm
| Arm | Count |
|---|---|
| Safety Analysis Group Five hundred and twenty-eight patients were enrolled at 100 sites across Japan, and 526 case reports were collected during the period of April 2017 to September 2019. The safety analysis population consisted of 510 patients. Among excluded patients, 15 patients were lost to follow-up, and one patient was not treated with aripiprazole. | 510 |
| Total | 510 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case report failures | 2 |
| Overall Study | Lost to Follow-up | 15 |
| Overall Study | Treatment not administered | 1 |
Baseline characteristics
| Characteristic | Safety Analysis Group |
|---|---|
| Age, Categorical <=18 years | 510 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 10.4 years STANDARD_DEVIATION 3.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 510 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Japan | 510 participants |
| Sex: Female, Male Female | 134 Participants |
| Sex: Female, Male Male | 376 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 510 |
| other Total, other adverse events | 82 / 510 |
| serious Total, serious adverse events | 3 / 510 |
Outcome results
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.
Time frame: Baseline, Week 4, 8, 16, 24, 52
Population: Twenty-one patients with the protocol deviations (including all effectiveness measures were not assessed after treatment: n = 11, all effectiveness measures were assessed over 7 days after last dose: n = 7, the daily dose was \> 15 mg: n = 2, all effectiveness were assessed after day 393: n = 1) were excluded, and then efficacy sample consisted of all participants who have Baseline and at least one Post-Baseline effectiveness evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Safety Analysis Group | Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. | Baseline | 19.8 score on a scale | Standard Deviation 9.5 |
| Safety Analysis Group | Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. | Week 4 | 14.7 score on a scale | Standard Deviation 8.8 |
| Safety Analysis Group | Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. | Week 8 | 12.9 score on a scale | Standard Deviation 8.1 |
| Safety Analysis Group | Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. | Week 16 | 12.7 score on a scale | Standard Deviation 8.3 |
| Safety Analysis Group | Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. | Week 24 | 13.4 score on a scale | Standard Deviation 8.9 |
| Safety Analysis Group | Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. | Week 52 | 13.1 score on a scale | Standard Deviation 9.1 |
| Safety Analysis Group | Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. | End-point (LOCF) | 13.0 score on a scale | Standard Deviation 9 |