Trial · NCT01617447

A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder

NCT01617447, Phase 3, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2017-04-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder. Trials, record NCT01617447. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01617447

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
NCT number: NCT01617447
Status: Completed
Phases: Phase 3
Enrollment: 92 participants, actual
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Conditions: Autistic Disorder
Interventions: Placebo of Aripiprazole, Aripiprazole
First posted: 2012-06-12
Last updated: 2017-04-11
Results first posted: 2017-04-11

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 in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score	baseline, 8 weeks after dosing	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 in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score	baseline, 8 weeks after dosing		units on a scale	MEAN

Source ClinicalTrials.gov

Results by group2

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 in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score	Aripiprazole		-11.4	Standard Error 1.3	units on a scale
Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score	Placebo		-7.5	Standard Error 1.4	units on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Aripiprazole	47
Overall Study	STARTED	Placebo	45
Overall Study	COMPLETED	Aripiprazole	47
Overall Study	COMPLETED	Placebo	42
Overall Study	NOT COMPLETED	Aripiprazole	0
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events142

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	Nausea	Gastrointestinal disorders	Aripiprazole	3	47	3
other	Nausea	Gastrointestinal disorders	Placebo	1	45	1
other	Vomiting	Gastrointestinal disorders	Aripiprazole	3	47	3
other	Vomiting	Gastrointestinal disorders	Placebo	0	45	0
other	Malaise	General disorders	Aripiprazole	3	47	3
other	Malaise	General disorders	Placebo	0	45	0
other	Gastroenteritis	Infections and infestations	Aripiprazole	1	47	1
other	Gastroenteritis	Infections and infestations	Placebo	4	45	4
other	Nasopharyngitis	Infections and infestations	Aripiprazole	10	47	18
other	Nasopharyngitis	Infections and infestations	Placebo	11	45	12

1 to 10 of 142Source ClinicalTrials.gov

See all 142 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Aripiprazole
Total, all-cause mortality	Placebo
Total, other adverse events	Aripiprazole	39	47
Total, other adverse events	Placebo	32	45
Total, serious adverse events	Aripiprazole	0	47
Total, serious adverse events	Placebo	1	45

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37811711	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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Aripiprazole vs Placebo: serious adverse events

Source Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01617447

GET https://conductscience.org/api/trials/v1/NCT01617447/events?page=2

API reference For AI assistants