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

This study has been completed.

Sponsor:

Collaborator:

Otsuka America Pharmaceutical

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00337571

First received: June 13, 2006

Last updated: August 3, 2010

Last verified: November 2009

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
Conditions:	Behavioral Symptoms 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	No text entered.
Aripiprazole 5 mg	No text entered.
Aripiprazole 10 mg	No text entered.
Aripiprazole 15 mg	No text entered.

Participant Flow: Overall Study

	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
Lack of Efficacy	3	0	0	0
Adverse Event	4	5	8	4
Withdrawal by Subject	2	2	1	0
Lost to Follow-up	3	1	0	1
Poor/noncompliance	1	1	1	1
No longer met study criteria	1	0	0	0
High Potassium level	0	0	0	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Placebo	No text entered.
Aripiprazole 5 mg	No text entered.
Aripiprazole 10 mg	No text entered.
Aripiprazole 15 mg	No text entered.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Aripiprazole 5 mg	Aripiprazole 10 mg	Aripiprazole 15 mg	Total
Number of Participants [units: participants]	52	53	59	54	218
Age, Customized [units: participants]
6 to 12 years	35	44	45	42	166
13 to 17 years	17	9	14	12	52
Gender [units: participants]
Female	4	6	9	4	23
Male	48	47	50	50	195
Race/Ethnicity, Customized [units: participants]
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
Race/Ethnicity, Customized [units: Participants]
Hispanic/Latino	8	5	7	5	25
Not Hispanic/Latino	44	48	52	49	193
Weight Group [units: Participants]
<40 kilograms	24	35	33	34	126
≥40 kilograms	28	18	26	20	92
Body Mass Index [units: kg/m2] Mean ± Standard Deviation	20.49 ± 4.777	19.91 ± 6.124	21.06 ± 6.649	20.14 ± 6.033	20.41 ± 5.933
Height [units: centimeters] Mean ± Standard Deviation	144.9 ± 18.82	136.5 ± 14.66	142.3 ± 17.87	139.3 ± 17.24	140.8 ± 17.38
Weight [units: kilograms] Mean ± Standard Deviation	45.6 ± 20.01	38.9 ± 18.26	44.8 ± 22.38	42.2 ± 22.99	42.9 ± 21.07

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: continuously 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:

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):1110-9.

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00337571 History of Changes
Other Study ID Numbers:	CN138-179
Study First Received:	June 13, 2006
Results First Received:	June 3, 2009
Last Updated:	August 3, 2010
Health Authority:	United States: Food and Drug Administration

To Top