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

This study has been completed.

Study NCT00332241 Information provided by Bristol-Myers Squibb

First Received on May 31, 2006. Last Updated on July 30, 2010 History of Changes

Results First Received: June 3, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Autistic Disorder
Interventions:	Drug: Aripiprazole Drug: Placebo

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Placebo	oral placebo once daily (QD)
Aripiprazole	oral aripiprazole 2 to 15 mg QD

Participant Flow: Overall Study

	Placebo	Aripiprazole
STARTED	51	47
COMPLETED	36	39
NOT COMPLETED	15	8
Lack of Efficacy	6	1
Adverse Event	3	5
Withdrawal by Subject	2	1
Lost to Follow-up	4	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Placebo	oral placebo once daily (QD)
Aripiprazole	oral aripiprazole 2 to 15 mg QD

Baseline Measures

	Placebo	Aripiprazole	Total
Number of Participants [units: participants]	51	47	98
Age, Customized [units: participants]
6 to 12 years	46	37	83
13 to 17 years	5	10	15
Gender [units: participants]
Female	7	5	12
Male	44	42	86
Race/Ethnicity, Customized [units: participants]
Asian	0	2	2
Native Hawaiian or Other Pacific Islander	0	1	1
Black or African American	7	11	18
White	41	32	73
Other	3	1	4
Race/Ethnicity, Customized [units: participants]
Hispanic/Latino	8	6	14
Not Hispanic/Latino	43	41	84
Weight Group [units: Participants]
<40 kilograms	32	26	58
≥40 kilograms	19	21	40
Body Mass Index [units: kg/cm2] Mean ± Standard Deviation	19.96 ± 5.392	21.08 ± 5.394	20.50 ± 5.395
Height [units: centimeters] Mean ± Standard Deviation	138.6 ± 14.7	140.9 ± 18.80	139.7 ± 16.74
Weight [units: kilograms] Mean ± Standard Deviation	40.6 ± 18.92	43.9 ± 19.15	42.2 ± 19.01

Outcome Measures

Show All Outcome Measures

1. Primary:

Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score [ Time Frame: Week 8 ]

Show Outcome Measure 1

2. Secondary:

Mean Clinical Global Impressions Improvement Scale (CGI-I) Score [ Time Frame: Week 8 ]

Show Outcome Measure 2

3. Secondary:

Number of Participants With Response at Week 8 [ Time Frame: Week 8 ]

Show Outcome Measure 3

4. Secondary:

Mean Change (Week 8 – Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only) [ Time Frame: Week 8 ]

Show Outcome Measure 4

5. Secondary:

Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores [ Time Frame: Week 8 ]

Show Outcome Measure 5

6. Secondary:

Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S) [ Time Frame: Week 8 ]

Show Outcome Measure 6

7. Secondary:

Summary of Safety [ Time Frame: continuous throughout the study ]

Show Outcome Measure 7

8. Secondary:

Change From Baseline in Body Weight [ Time Frame: Week 8 ]

Show Outcome Measure 8

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@BMS.com

Publications:

Owen R, Sikich L, Marcus RN, Corey-Lisle P, Manos G, McQuade RD, Carson WH, Findling RL. Aripiprazole in the treatment of irritability in children and adolescents with autistic disorder. Pediatrics. 2009 Dec;124(6):1533-40.

Publications automatically indexed to this study:

Aman MG, Kasper W, Manos G, Mathew S, Marcus R, Owen R, Mankoski R. Line-item analysis of the Aberrant Behavior Checklist: results from two studies of aripiprazole in the treatment of irritability associated with autistic disorder. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):415-22.

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00332241 History of Changes
Other Study ID Numbers:	CN138-178
Study First Received:	May 31, 2006
Results First Received:	June 3, 2009
Last Updated:	July 30, 2010
Health Authority:	United States: Food and Drug Administration