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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole oral product | Drug | oral administration of aripiprazole |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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naive patients with aripiprasole
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| Name | Affiliation | Role |
|---|---|---|
| Pharmacovigilance | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otsuka Pharmaceutical Co., Ltd. | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33888067 | Derived | 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. |
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Patients newly treated with aripiprazole for irritability associated with autism spectrum disorder (ASD) in children and adolescents (≥6 years and <18 years) were included.
This surveillance was conducted in 528 participants from 100 trial sites in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 4, 8, 16, 24, 52 |
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Adverse events were observed from first dose until follow-up for 52 weeks.
The adverse events (if any occurred), onset date, seriousness, outcome, date of outcome, causality to aripiprazole, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epilepsy | Nervous system disorders | MedDRA ver.22.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA ver.22.1 | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Section Chief of Pharmacovigilance | Otsuka Pharmaceutical Co., Ltd. | +81-3-6717-1400 | Sugimoto.Yuna@otsuka.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 6, 2016 | Aug 16, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 26, 2020 | Aug 23, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Description |
|---|
| OG000 | 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. |
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|
| 0 |
| 510 |
| 3 |
| 510 |
| 82 |
| 510 |
| Partial seizures | Nervous system disorders | MedDRA ver.22.1 | Non-systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA ver.22.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA ver.22.1 | Non-systematic Assessment |
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| Impulsive behaviour | Psychiatric disorders | MedDRA ver.22.1 | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA ver.22.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA ver.22.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA ver.22.1 | Non-systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA ver.22.1 | Non-systematic Assessment |
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| Obesity | Metabolism and nutrition disorders | MedDRA ver.22.1 | Non-systematic Assessment |
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