Trial · NCT00332241
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD).
NCT00332241, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2009-07-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD). Trials, record NCT00332241. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00332241
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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
- NCT00332241
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 98 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Autistic Disorder
- Interventions
- Aripiprazole, Placebo
- First posted
- 2006-06-01
- 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 decrease 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 | continuous 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 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. 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 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. 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 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF. | participant | 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 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. 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 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF. | units of a scale | MEAN |
| SECONDARY | Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S) | Week 8 | Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF. | units on a scale | MEAN |
| SECONDARY | Summary of Safety | continuous throughout the study | Safety population=all randomized participants minus 1 patient in the placebo group lost to follow-up. Data set is LOCF. | participants | NUMBER |
| SECONDARY | Change From Baseline in Body Weight | Week 8 | Safety population=all randomized participants minus 1 patient in the placebo group lost to follow-up. Includes all participants with weight measurement at baseline and timepoint. Data set is LOCF. | kilograms | MEAN |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score | Placebo | -5.0 | Standard Error 1.43 | units on a scale | |
| Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score | Aripiprazole | -12.9 | Standard Error 1.44 | units on a scale | |
| Mean Clinical Global Impressions Improvement Scale (CGI-I) Score | Placebo | 3.6 | Standard Error 0.18 | units on a scale | |
| Mean Clinical Global Impressions Improvement Scale (CGI-I) Score | Aripiprazole | 2.2 | Standard Error 0.18 | units on a scale | |
| Number of Participants With Response at Week 8 | Placebo | 7 | participant | ||
| Number of Participants With Response at Week 8 | Aripiprazole | 24 | participant | ||
| Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only) | Placebo | -0.8 | Standard Error 0.52 | units on a scale | |
| Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only) | Aripiprazole | -3.8 | Standard Error 0.50 | units on a scale | |
| Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores | Placebo | ABC Hyperactivity Subscale Score | -2.8 | Standard Error 1.5 | units of a scale |
| Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores | Aripiprazole | ABC Hyperactivity Subscale Score | -12.7 | Standard Error 1.52 | units of a scale |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 51 | |
| Overall Study | STARTED | Aripiprazole | 47 | |
| Overall Study | COMPLETED | Placebo | 36 | |
| Overall Study | COMPLETED | Aripiprazole | 39 | |
| Overall Study | NOT COMPLETED | Placebo | 15 | |
| Overall Study | NOT COMPLETED | Aripiprazole | 8 |
Source ClinicalTrials.gov
Adverse events32
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 | INSOMNIA | Psychiatric disorders | Aripiprazole | 3 | 47 | |
| other | INSOMNIA | Psychiatric disorders | Placebo | 4 | 50 | |
| other | AGGRESSION | Psychiatric disorders | Aripiprazole | 1 | 47 | |
| other | AGGRESSION | Psychiatric disorders | Placebo | 4 | 50 | |
| other | TREMOR | Nervous system disorders | Aripiprazole | 4 | 47 | |
| other | TREMOR | Nervous system disorders | Placebo | 0 | 50 | |
| other | DROOLING | Nervous system disorders | Aripiprazole | 4 | 47 | |
| other | DROOLING | Nervous system disorders | Placebo | 0 | 50 | |
| other | HEADACHE | Nervous system disorders | Aripiprazole | 3 | 47 | |
| other | HEADACHE | Nervous system disorders | Placebo | 8 | 50 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse 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 | 38 | 47 |
| Total, other adverse events | Placebo | 29 | 50 |
| Total, serious adverse events | Aripiprazole | 0 | 47 |
| Total, serious adverse events | Placebo | 0 | 50 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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.
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/NCT00332241
GET https://conductscience.org/api/trials/v1/NCT00332241/results?page=2