CompletedNCT00337571Updated May 13, 2026Results posted

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

A Phase 3 interventional study of Aripiprazole and Placebo in Behavioral Symptoms and Autistic Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 31 sites in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. (part of Otsuka Holdings Co., Ltd.) · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 218
Allocation: Randomized
Ages: 6 Years to 17 Years
Sex: All

Study summary

This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).

Conditions studied

Behavioral Symptoms
Autistic Disorder

Browse trials for

Keywords

Serious behavioral problems in children and adolescents with AD

In context

Behavioral Symptoms

135 studies on the registry are indexed under Behavioral Symptoms; 18 are open to participants now.

This study's enrollment of 218 is above the median of 93 across 114 interventional studies indexed under Behavioral Symptoms.

Browse Behavioral Symptoms studies →

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 295 studies on the registry; 18 are open to participants now.

Of its 106 completed or terminated interventional studies of FDA-regulated products, 71 (67%) have results posted.

Browse Otsuka Pharmaceutical Development & Commercialization, Inc. studies →All Otsuka Holdings Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Meets current , Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for AD and demonstrates serious behavioral problems; diagnosis confirmed by Autism, Diagnostic Interview-Revised (ADI-R).
CGI score > = 4 AND an ABC Irritability/Agitation subscale score > = 18 at screening and baseline (randomization)
Mental age of at least 18 months
Male or female 6 to 17 years of age inclusive, at the time of randomization

Exclusion criteria

Exclusion Criteria:

Patients considered treatment resistant to neuroleptic medication based on lack of therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks each
Patients previously treated and not responding to aripiprazole treatment
The patient is currently diagnosed with another disorder on the autism spectrum, including PDD-NOS, Asperger's Disorder, Rett's Disorder, Fragile-X Syndrome or Childhood Disintegrative Disorder
Current diagnosis of bipolar disorder, psychosis, schizophrenia, or major depression
A seizure in the past year
History of severe head trauma or stroke
Non-pharmacologic therapy (e.g., psychotherapy, behavior modification) should be stable prior to screening and consistent throughout the study

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria: The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 218 participants (actual)

Study arms

Experimental
A1
5 mg
Drug: Aripiprazole
Experimental
A2
10 mg
Drug: Aripiprazole
Experimental
A3
15 mg
Drug: Aripiprazole
Placebo comparator
B1
Drug: Placebo

Interventions

DrugAripiprazole
Tablets, Oral, once daily, 8 weeks
Also known as: Abilify
DrugPlacebo
Tablets, Oral, once daily, 8 weeks

What researchers measure

Primary outcomes

Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score
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.
Time frame: Week 8

Secondary outcomes

Mean Clinical Global Impressions Improvement Scale (CGI-I) Score
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).
Time frame: Week 8
Number of Participants With Response at 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.
Time frame: Week 8
Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)
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.
Time frame: Week 8
Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores
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.
Time frame: Week 8
Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)
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.
Time frame: Week 8
Summary of Safety
Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation
Time frame: continuously throughout the study
Change From Baseline in Body Weight
Adjusted mean change (Week 8 - baseline) in body weight
Time frame: Week 8

Results

Posted Jul 23, 2009

Participant flow

Participant flow — Overall Study
Milestone	Placebo	Aripiprazole 5 mg	Aripiprazole 10 mg	Aripiprazole 15 mg
Started	52	53	59	54
Completed	38	44	49	47
Not completed	14	9	10	7
Withdrew: Lack of efficacy	3	0	0	0
Withdrew: Adverse event	4	5	8	4
Withdrew: Withdrawal by subject	2	2	1	0
Withdrew: Lost to follow-up	3	1	0	1
Withdrew: Poor/noncompliance	1	1	1	1
Withdrew: No longer met study criteria	1	0	0	0
Withdrew: High potassium level	0	0	0	1

Outcome measures

PrimaryMean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score

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.

Time frame:: Week 8
Reported as:: Mean · units on a scale

Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score
units on a scale	Placebo	Aripiprazole 5 mg	Aripiprazole 10 mg	Aripiprazole 15 mg
Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score	-8.4 ± 1.39	-12.4 ± 1.36	-13.2 ± 1.25	-14.4 ± 1.31

SecondaryMean Clinical Global Impressions Improvement Scale (CGI-I) Score

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).

Time frame:: Week 8
Reported as:: Mean · units on a scale

Mean Clinical Global Impressions Improvement Scale (CGI-I) Score
units on a scale	Placebo	Aripiprazole 5 mg	Aripiprazole 10 mg	Aripiprazole 15 mg
Mean Clinical Global Impressions Improvement Scale (CGI-I) Score	3.3 ± 0.18	2.6 ± 0.17	2.5 ± 0.16	2.5 ± 0.17

SecondaryNumber of Participants With Response at 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.

Time frame:: Week 8
Reported as:: Number · Participants

Number of Participants With Response at Week 8
Participants	Placebo	Aripiprazole 5 mg	Aripiprazole 10 mg	Aripiprazole 15 mg
Number of Participants With Response at Week 8	17	29	29	28

SecondaryMean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)

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.

Time frame:: Week 8
Reported as:: Mean · units on a scale

Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)
units on a scale	Placebo	Aripiprazole 5 mg	Aripiprazole 10 mg	Aripiprazole 15 mg
Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)	-1.7 ± 0.50	-2.6 ± 0.50	-2.4 ± 0.44	-3.2 ± 0.47

SecondaryMean Change (Week 8 - Baseline) in the Other ABC Subscale Scores

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.

Time frame:: Week 8
Reported as:: Mean · units on a scale

Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores
units on a scale	Placebo	Aripiprazole 5 mg	Aripiprazole 10 mg	Aripiprazole 15 mg
ABC Hyperactivity Subscale Score	-7.7 ± 1.67	-14.0 ± 1.64	-13.3 ± 1.50	-16.3 ± 1.59
ABC Stereotypy Subscale Score	-1.8 ± 0.69	-4.5 ± 0.68	-4.2 ± 0.63	-4.5 ± 0.66
ABC Inappropriate Speech Subscale Score	-1.1 ± 0.46	-2.0 ± 0.45	-1.8 ± 0.41	-2.3 ± 0.43
ABC Social Withdrawal Subscale Score	-5.2 ± 1.16	-5.8 ± 1.15	-4.9 ± 1.06	-7.9 ± 1.11

SecondaryMean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)

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.

Time frame:: Week 8
Reported as:: Mean · units on a scale

Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)
units on a scale	Placebo	Aripiprazole 5 mg	Aripiprazole 10 mg	Aripiprazole 15 mg
Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)	-0.6 ± 0.16	-0.9 ± 0.15	-1.0 ± 0.13	-1.1 ± 0.15

SecondarySummary of Safety

Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation

Time frame:: continuously throughout the study
Reported as:: Number · participants

Summary of Safety
participants	Placebo	Aripiprazole 5 mg	Aripiprazole 10 mg	Aripiprazole 15 mg
Deaths	0	0	0	0
Treatment-emergent SAEs	0	1	1	0
AEs leading to discontinuation of study medication	4	5	8	4
Treatment-emergent AEs overall	37	46	53	46
Treatment-emergent AEs related to study medication	22	37	50	39
Treatment-emergent extrapyramidal symptom AEs	6	12	13	12

SecondaryChange From Baseline in Body Weight

Adjusted mean change (Week 8 - baseline) in body weight

Time frame:: Week 8
Reported as:: Mean · kilograms

Change From Baseline in Body Weight
kilograms	Placebo	Aripiprazole 5 mg	Aripiprazole 10 mg	Aripiprazole 15 mg
Change From Baseline in Body Weight	0.3 ± 0.32	1.3 ± 0.31	1.3 ± 0.29	1.5 ± 0.30

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Aripiprazole 10 mg	—	1/59 (1.7%)	51/59 (86.4%)
Aripiprazole 15 mg	—	0/54 (0%)	42/54 (77.8%)
Aripiprazole 5 mg	—	1/52 (1.9%)	37/52 (71.2%)
Placebo	—	0/51 (0%)	31/51 (60.8%)

Most frequent serious events

Most frequent serious events
Event	Aripiprazole 10 mg	Aripiprazole 15 mg	Aripiprazole 5 mg	Placebo
PRESYNCOPENervous system disorders	0/59	0/54	1/52	0/51
AGGRESSIONPsychiatric disorders	1/59	0/54	0/52	0/51

Most frequent other events

Showing 10 of 35

Most frequent other events
Event	Aripiprazole 10 mg	Aripiprazole 15 mg	Aripiprazole 5 mg	Placebo
SEDATIONNervous system disorders	17/59	13/54	9/52	3/51
FATIGUEGeneral disorders	13/59	10/54	2/52	0/51
VOMITINGGastrointestinal disorders	12/59	5/54	5/52	4/51
INCREASED APPETITEMetabolism and nutrition disorders	3/59	7/54	10/52	2/51
COUGHRespiratory, thoracic and mediastinal disorders	4/59	0/54	8/52	2/51
DROOLINGNervous system disorders	8/59	5/54	2/52	0/51
TREMORNervous system disorders	7/59	6/54	4/52	0/51
PYREXIAGeneral disorders	7/59	5/54	3/52	0/51
INSOMNIAPsychiatric disorders	5/59	2/54	1/52	6/51
NASOPHARYNGITISInfections and infestations	5/59	5/54	6/52	2/51

Baseline characteristics

Age, Customized
Age, Customized(participants)	Placebo	Aripiprazole 5 mg	Aripiprazole 10 mg	Aripiprazole 15 mg	Total
6 to 12 years	35	44	45	42	166
13 to 17 years	17	9	14	12	52

Sex/Gender, Customized
Sex/Gender, Customized(Participants)	Placebo	Aripiprazole 5 mg	Aripiprazole 10 mg	Aripiprazole 15 mg	Total
Female	4	6	9	4	23
Male	48	47	50	50	195

Race, Customized
Race, Customized(participants)	Placebo	Aripiprazole 5 mg	Aripiprazole 10 mg	Aripiprazole 15 mg	Total
Asian	3	1	2	0	6
Native Hawaiian or Other Pacific Islander	0	0	0	1	1
Black or African American	13	13	15	9	50
White	35	37	41	42	155
Other	1	2	1	2	6

Ethnicity, Customized
Ethnicity, Customized(Participants)	Placebo	Aripiprazole 5 mg	Aripiprazole 10 mg	Aripiprazole 15 mg	Total
Hispanic/Latino	8	5	7	5	25
Not Hispanic/Latino	44	48	52	49	193

Weight Group
Weight Group(Participants)	Placebo	Aripiprazole 5 mg	Aripiprazole 10 mg	Aripiprazole 15 mg	Total
<40 kilograms	24	35	33	34	126
≥40 kilograms	28	18	26	20	92

Body Mass Index
Body Mass Index(kg/m2)	Placebo	Aripiprazole 5 mg	Aripiprazole 10 mg	Aripiprazole 15 mg	Total
Mean	20.49 ± 4.777	19.91 ± 6.124	21.06 ± 6.649	20.14 ± 6.033	20.41 ± 5.933

Height
Height(centimeters)	Placebo	Aripiprazole 5 mg	Aripiprazole 10 mg	Aripiprazole 15 mg	Total
Mean	144.9 ± 18.82	136.5 ± 14.66	142.3 ± 17.87	139.3 ± 17.24	140.8 ± 17.38

Weight
Weight(kilograms)	Placebo	Aripiprazole 5 mg	Aripiprazole 10 mg	Aripiprazole 15 mg	Total
Mean	45.6 ± 20.01	38.9 ± 18.26	44.8 ± 22.38	42.2 ± 22.99	42.9 ± 21.07

Study locations

31 sites

University Of Alabama At Birmingham
Birmingham, Alabama 35294, United States
Harmonex Neuroscience
Dothan, Alabama 36303, United States
Southwest Autism Research And Resource Center
Phoenix, Arizona 85006, United States
Clinical Innovations, Inc.
Huntington Beach, California 92647, United States
University Of California-Davis Medical Center
Sacramento, California 95817, United States
Stanford University School Of Medicine
Stanford, California 94305, United States
The Children'S Hospital
Aurora, Colorado 80045, United States
Marsella, Gregory
Boca Raton, Florida 33432, United States
University Of Florida
Gainesville, Florida 32611, United States
University Of South Florida
Tampa, Florida 33613, United States
Institute For Behavioral Medicine
Smyrna, Georgia 30080, United States
University Of Illinois At Chicago
Chicago, Illinois 60606, United States
Cambridge Health Alliance
Medford, Massachusetts 02139, United States
Ladders Clinic
Wellesley, Massachusetts 02481, United States
Children'S Hospital Of Michigan
Detroit, Michigan 48201, United States
Regions Hospital
Saint Paul, Minnesota 55101, United States
Children'S Mercy Hospital
Kansas City, Missouri 64108, United States
Munroe-Meyer Institute
Omaha, Nebraska 68198, United States
North Shore - Long Island Jewish Health System
Bethpage, New York 11714, United States
Seaver And New York Autism Center Of Excellence
New York, New York 10029, United States
Richmond Behavioral Associates
Staten Island, New York 10312, United States
Mission Hospitals
Asheville, North Carolina 28801, United States
Duke Child And Family Study Center
Durham, North Carolina 27710, United States
The Nisonger Center
Columbus, Ohio 43210, United States
Cutting Edge Research
Oklahoma City, Oklahoma 73116, United States
Western Psychiatric Institute And Clinic
Pittsburgh, Pennsylvania 15203, United States
Dallas Pediatric Neurology Associates
Dallas, Texas 75230, United States
Bayou City Research, Ltd.
Houston, Texas 77007, United States
Children'S National Medical Center
Fairfax, Virginia 22031, United States
Pacific Institute Of Medical Sciences
Bothell, Washington 98011, United States
Children'S Hospital Of Wisconsin
Milwaukee, Wisconsin 53201, United States

References and documents

Publications

Marcus RN, Owen R, Kamen L, Manos G, McQuade RD, Carson WH, Aman MG. A placebo-controlled, fixed-dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder. J Am Acad Child Adolesc Psychiatry. 2009 Nov;48(11):1110-1119. doi: 10.1097/CHI.0b013e3181b76658. PubMed 19797985 ↗
Mankoski R, Stockton G, Manos G, Marler S, McQuade R, Forbes RA, Marcus R. Aripiprazole treatment of irritability associated with autistic disorder and the relationship between prior antipsychotic exposure, adverse events, and weight change. J Child Adolesc Psychopharmacol. 2013 Oct;23(8):572-6. doi: 10.1089/cap.2012.0075. PubMed 24138011 ↗
Robb AS, Andersson C, Bellocchio EE, Manos G, Rojas-Fernandez C, Mathew S, Marcus R, Owen R, Mankoski R. Safety and tolerability of aripiprazole in the treatment of irritability associated with autistic disorder in pediatric subjects (6-17 years old):results from a pooled analysis of 2 studies. Prim Care Companion CNS Disord. 2011;13(1):PCC.10m01008. doi: 10.4088/PCC.10m01008gry. PubMed 21731831 ↗

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2006 to primary completion in Jun 2008, 24 months.

Results were first posted in Jul 2009, 1 year 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 13, 2006
First posted: Jun 16, 2006
StartActual: Jun 1, 2006
Primary completionActual: Jun 1, 2008
CompletionActual: Jun 1, 2008
Results first posted: Jul 23, 2009
Last update: May 13, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00337571
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators: Otsuka America Pharmaceutical
Responsible party: Sponsor
First posted: Jun 16, 2006
Start date: Jun 1, 2006
Primary completion: Jun 1, 2008
Completion: Jun 1, 2008
Results posted: Jul 23, 2009
Last update: May 13, 2026

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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