Trial · NCT01617460
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
NCT01617460, Phase 3, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2017-10-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder. Trials, record NCT01617460. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01617460
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
- NCT number
- NCT01617460
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 86 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Autistic Disorder
- Interventions
- Aripiprazole
- First posted
- 2012-06-12
- Last updated
- 2024-08-06
- Results first posted
- 2017-10-20
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
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 Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score | Baseline, the final administration | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score | Aripiprazole | -3.2 | Standard Deviation 8.1 | units 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 | Aripiprazole | 86 | |
| Overall Study | COMPLETED | Aripiprazole | 46 | |
| Overall Study | NOT COMPLETED | Aripiprazole | 40 |
Source ClinicalTrials.gov
Adverse events36
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 | Conjunctivitis allergic | Eye disorders | Aripiprazole | 5 | 86 | |
| other | Dental caries | Gastrointestinal disorders | Aripiprazole | 8 | 86 | |
| other | Diarrhoea | Gastrointestinal disorders | Aripiprazole | 5 | 86 | |
| other | Nausea | Gastrointestinal disorders | Aripiprazole | 6 | 86 | |
| other | Salivary hypersecretion | Gastrointestinal disorders | Aripiprazole | 6 | 86 | |
| other | Vomiting | Gastrointestinal disorders | Aripiprazole | 12 | 86 | |
| other | Pyrexia | General disorders | Aripiprazole | 8 | 86 | |
| other | Bronchitis | Infections and infestations | Aripiprazole | 5 | 86 | |
| other | Gastroenteritis | Infections and infestations | Aripiprazole | 10 | 86 | |
| other | Influenza | Infections and infestations | Aripiprazole | 25 | 86 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aripiprazole | ||
| Total, other adverse events | Aripiprazole | 84 | 86 |
| Total, serious adverse events | Aripiprazole | 10 | 86 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28941259 | 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/NCT01617460
GET https://conductscience.org/api/trials/v1/NCT01617460/events?page=2