Trial · NCT03179787
Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism
NCT03179787, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2021-09-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism. Trials, record NCT03179787. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03179787
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism
- NCT number
- NCT03179787
- Status
- Completed
- Enrollment
- 528 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Autism
- Interventions
- Aripiprazole oral product
- First posted
- 2017-06-07
- Last updated
- 2021-09-16
- Results first posted
- 2021-09-16
- 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.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. | Baseline, Week 4, 8, 16, 24, 52 | 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. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. | Safety Analysis Group | Baseline | 19.8 | Standard Deviation 9.5 | score on a scale |
| Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. | Safety Analysis Group | Week 4 | 14.7 | Standard Deviation 8.8 | score on a scale |
| Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. | Safety Analysis Group | Week 8 | 12.9 | Standard Deviation 8.1 | score on a scale |
| Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. | Safety Analysis Group | Week 16 | 12.7 | Standard Deviation 8.3 | score on a scale |
| Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. | Safety Analysis Group | Week 24 | 13.4 | Standard Deviation 8.9 | score on a scale |
| Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. | Safety Analysis Group | Week 52 | 13.1 | Standard Deviation 9.1 | score on a scale |
| Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. | Safety Analysis Group | End-point (LOCF) | 13.0 | Standard Deviation 9.0 | score on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Safety Analysis Group | 528 | |
| Overall Study | COMPLETED | Safety Analysis Group | 510 | |
| Overall Study | NOT COMPLETED | Safety Analysis Group | 18 |
Source ClinicalTrials.gov
Adverse events11
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Somnolence | Nervous system disorders | Safety Analysis Group | 48 | 510 | 48 |
| other | Weight increased | Investigations | Safety Analysis Group | 18 | 510 | 18 |
| other | Headache | Nervous system disorders | Safety Analysis Group | 8 | 510 | 8 |
| other | Nausea | Gastrointestinal disorders | Safety Analysis Group | 7 | 510 | 7 |
| other | Increased appetite | Metabolism and nutrition disorders | Safety Analysis Group | 6 | 510 | 6 |
| other | Obesity | Metabolism and nutrition disorders | Safety Analysis Group | 5 | 510 | 5 |
| serious | Epilepsy | Nervous system disorders | Safety Analysis Group | 1 | 510 | 1 |
| serious | Partial seizures | Nervous system disorders | Safety Analysis Group | 1 | 510 | 1 |
| serious | Renal impairment | Renal and urinary disorders | Safety Analysis Group | 1 | 510 | 1 |
| serious | Insomnia | Psychiatric disorders | Safety Analysis Group | 1 | 510 | 1 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Safety Analysis Group | 0 | 510 |
| Total, other adverse events | Safety Analysis Group | 82 | 510 |
| Total, serious adverse events | Safety Analysis Group | 3 | 510 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33888067 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03179787
GET https://conductscience.org/api/trials/v1/NCT03179787/registered