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

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Condition:	Autistic Disorder
Interventions:	Drug: Aripiprazole Drug: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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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

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

Number of Participants With Response at Week 8 [ Week 8 ]

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4. Secondary:

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

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Measure Type	Secondary
Measure Title	Mean Change (Week 8 – Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)
Measure Description	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.
Time Frame	Week 8
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

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

Measured Values

	Placebo	Aripiprazole
Number of Participants Analyzed [units: participants]	44	43
Mean Change (Week 8 – Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only) [units: units on a scale] Mean ± Standard Error	-0.8 ± 0.52	-3.8 ± 0.50

No statistical analysis provided for Mean Change (Week 8 – Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)

5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

Summary of Safety [ continuous throughout the study ]

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8. Secondary:

Change From Baseline in Body Weight [ Week 8 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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
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Results Point of Contact:

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

No publications provided

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