Trial · NCT00337571

Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)

NCT00337571, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2009-07-23

3 sourcestrials-2026-11-12-0.5.0

Download JSON

Cite this record

ConductScience Library. Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD). Trials, record NCT00337571. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00337571

On this page

Trial

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

Title: Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
NCT number: NCT00337571
Status: Completed
Phases: Phase 3
Enrollment: 218 participants, actual
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions: Behavioral Symptoms, Autistic Disorder
Interventions: Aripiprazole, Placebo
First posted: 2006-06-16
Last updated: 2026-05-13
Results first posted: 2009-07-23

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score	Week 8	The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation. Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales. A decrease in score indicates improvement.
Secondary	Mean Clinical Global Impressions Improvement Scale (CGI-I) Score	Week 8	The CGI scale is a clinician-rated global assessment of a patient's improvement over time. Baseline assessment rated a patient's condition on a 7-point scale (1=no symptoms, 7=very severe symptoms). Subsequent assessed improvement relative to baseline symptoms on a 7-point CGI-I item scale (1=very much improved, 7=very much worse).
Secondary	Number of Participants With Response at Week 8	Week 8	Response defined as a ≥ 25% reduction from baseline to endpoint in the ABC Irritability Subscale score and a CGI-I score of 1 or 2 at endpoint.
Secondary	Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)	Week 8	CY-BOCS=10-item assessment of obsessive-compulsive symptoms in patients \<18 years. 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale (0=no symptoms/minimum severity, 4=extreme symptoms/maximum severity). A decreased in value indicates improvement.
Secondary	Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores	Week 8	Mean change (Week 8 - baseline) in the other ABC subscale scores (lethargy/social withdrawal; stereotypic behavior; hyperactivity/ noncompliance; inappropriate speech). A decrease in value indicates improvement.
Secondary	Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)	Week 8	A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=no symptoms; 7=very severe symptoms). The patient's improvement relative to the symptoms at baseline on were assessed on a 7-point CGI-I (1=very much improved; 7=very much worse). A decrease in value indicates improvement.
Secondary	Summary of Safety	continuously throughout the study	Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation
Secondary	Change From Baseline in Body Weight	Week 8	Adjusted mean change (Week 8 - baseline) in body weight

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score	Week 8	Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.	units on a scale	MEAN
SECONDARY	Mean Clinical Global Impressions Improvement Scale (CGI-I) Score	Week 8	Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.	units on a scale	MEAN
SECONDARY	Number of Participants With Response at Week 8	Week 8	Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.	Participants	NUMBER
SECONDARY	Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)	Week 8	Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.	units on a scale	MEAN
SECONDARY	Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores	Week 8	Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.	units on a scale	MEAN
SECONDARY	Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)	Week 8	Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.	units on a scale	MEAN
SECONDARY	Summary of Safety	continuously throughout the study	Safety population=all randomized participants minus 1 patients in the placebo group (no longer met study criteria), and 1 participant in the 5-mg group who withdrew consent.	participants	NUMBER
SECONDARY	Change From Baseline in Body Weight	Week 8	Safety population=all randomized participants minus 3 patients in the placebo group (1 no longer met study criteria, 2 did not have measurement at baseline and Week 8), and 1 participant in the 5-mg group who withdrew consent. Data set is LOCF.	kilograms	MEAN

Source ClinicalTrials.gov

Results by group64

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score	Placebo	-8.4	Standard Error 1.39	units on a scale
Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score	Aripiprazole 5 mg	-12.4	Standard Error 1.36	units on a scale
Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score	Aripiprazole 10 mg	-13.2	Standard Error 1.25	units on a scale
Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score	Aripiprazole 15 mg	-14.4	Standard Error 1.31	units on a scale
Mean Clinical Global Impressions Improvement Scale (CGI-I) Score	Placebo	3.3	Standard Error 0.18	units on a scale
Mean Clinical Global Impressions Improvement Scale (CGI-I) Score	Aripiprazole 5 mg	2.6	Standard Error 0.17	units on a scale
Mean Clinical Global Impressions Improvement Scale (CGI-I) Score	Aripiprazole 10 mg	2.5	Standard Error 0.16	units on a scale
Mean Clinical Global Impressions Improvement Scale (CGI-I) Score	Aripiprazole 15 mg	2.5	Standard Error 0.17	units on a scale
Number of Participants With Response at Week 8	Placebo	17		Participants
Number of Participants With Response at Week 8	Aripiprazole 5 mg	29		Participants

1 to 10 of 64Source ClinicalTrials.gov

See all 64 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	52
Overall Study	STARTED	Aripiprazole 5 mg	53
Overall Study	STARTED	Aripiprazole 10 mg	59
Overall Study	STARTED	Aripiprazole 15 mg	54
Overall Study	COMPLETED	Placebo	38
Overall Study	COMPLETED	Aripiprazole 5 mg	44
Overall Study	COMPLETED	Aripiprazole 10 mg	49
Overall Study	COMPLETED	Aripiprazole 15 mg	47
Overall Study	NOT COMPLETED	Placebo	14
Overall Study	NOT COMPLETED	Aripiprazole 5 mg	9

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events148

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
other	WEIGHT INCREASED	Investigations	Aripiprazole 10 mg	1	59
other	WEIGHT INCREASED	Investigations	Aripiprazole 15 mg	2	54
other	WEIGHT INCREASED	Investigations	Aripiprazole 5 mg	4	52
other	WEIGHT INCREASED	Investigations	Placebo	1	51
other	INSOMNIA	Psychiatric disorders	Aripiprazole 10 mg	5	59
other	INSOMNIA	Psychiatric disorders	Aripiprazole 15 mg	2	54
other	INSOMNIA	Psychiatric disorders	Aripiprazole 5 mg	1	52
other	INSOMNIA	Psychiatric disorders	Placebo	6	51
other	AGGRESSION	Psychiatric disorders	Aripiprazole 10 mg	2	59
other	AGGRESSION	Psychiatric disorders	Aripiprazole 15 mg	0	54

1 to 10 of 148Source ClinicalTrials.gov

See all 148 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Aripiprazole 10 mg
Total, all-cause mortality	Aripiprazole 15 mg
Total, all-cause mortality	Aripiprazole 5 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Aripiprazole 10 mg	51	59
Total, other adverse events	Aripiprazole 15 mg	42	54
Total, other adverse events	Aripiprazole 5 mg	37	52
Total, other adverse events	Placebo	31	51
Total, serious adverse events	Aripiprazole 10 mg	1	59
Total, serious adverse events	Aripiprazole 15 mg	0	54

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19797985	BACKGROUND	PubMed
21731831	DERIVED	PubMed
24138011	DERIVED	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.

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/NCT00337571

GET https://conductscience.org/api/trials/v1/NCT00337571/results?page=2

API reference For AI assistants