Autistic Disorder
Conditions
Keywords
Autistic Disorder, children and adolescents, aripiprazole, Long-term safety study, children and adolescents
Brief summary
The objective of this study is to investigate the safety and efficacy of aripiprazole orally administered over long term in subjects who complete a short-term treatment study of pediatric Autistic Disorder (031-11-002 study).
Interventions
DRUGAripiprazole
Flexibly dose administered orally once daily
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* The patient meets Autistic disorder diagnostic criteria defined in DSM-IV-TR. * The patient has completed the 031-11-002 study (the patient has visited the hospital during week8) * Inpatient or outpatient status
Exclusion criteria
* The patient is currently diagnosed with another disorder on the autism spectrum in DSM-IV-TR, including Asperger's, Rett's Disorder, PDD-NOS, Childhood Disintegrative Disorder, or Fragile-X Syndrome. * Patients who fall under a contraindication listed in the ABILIFY package insert * Others
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score | Baseline, the final administration | The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aripiprazole Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued.
The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. | 86 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 10 |
| Overall Study | Physician Decision | 16 |
| Overall Study | Protocol Violation | 5 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Aripiprazole |
|---|---|
| Age, Categorical <=18 years | 86 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 10.0 years STANDARD_DEVIATION 3 |
| Region of Enrollment Japan | 86 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 84 / 86 |
| serious Total, serious adverse events | 10 / 86 |
Outcome results
Primary
Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score
The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition.
Time frame: Baseline, the final administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aripiprazole | Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score | -3.2 units on a scale | Standard Deviation 8.1 |