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Trial record 11 of 31 for:    Developmental Disabilities | ( Map: Alabama, United States )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00337571
Recruitment Status : Completed
First Posted : June 16, 2006
Results First Posted : July 23, 2009
Last Update Posted : December 2, 2013
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Behavioral Symptoms
Autistic Disorder
Interventions Drug: Aripiprazole
Drug: Placebo
Enrollment 218
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Aripiprazole 5 mg Aripiprazole 10 mg Aripiprazole 15 mg
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
Started 52 53 59 54
Completed 38 44 49 47
Not Completed 14 9 10 7
Reason Not Completed
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
Arm/Group Title Placebo Aripiprazole 5 mg Aripiprazole 10 mg Aripiprazole 15 mg Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 52 53 59 54 218
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants 53 participants 59 participants 54 participants 218 participants
6 to 12 years 35 44 45 42 166
13 to 17 years 17 9 14 12 52
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 53 participants 59 participants 54 participants 218 participants
Female
4
   7.7%
6
  11.3%
9
  15.3%
4
   7.4%
23
  10.6%
Male
48
  92.3%
47
  88.7%
50
  84.7%
50
  92.6%
195
  89.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants 53 participants 59 participants 54 participants 218 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants 53 participants 59 participants 54 participants 218 participants
Hispanic/Latino 8 5 7 5 25
Not Hispanic/Latino 44 48 52 49 193
Weight Group  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants 53 participants 59 participants 54 participants 218 participants
<40 kilograms 24 35 33 34 126
≥40 kilograms 28 18 26 20 92
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 52 participants 53 participants 59 participants 54 participants 218 participants
20.49  (4.777) 19.91  (6.124) 21.06  (6.649) 20.14  (6.033) 20.41  (5.933)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 52 participants 53 participants 59 participants 54 participants 218 participants
144.9  (18.82) 136.5  (14.66) 142.3  (17.87) 139.3  (17.24) 140.8  (17.38)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 52 participants 53 participants 59 participants 54 participants 218 participants
45.6  (20.01) 38.9  (18.26) 44.8  (22.38) 42.2  (22.99) 42.9  (21.07)
1.Primary Outcome
Title Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.
Arm/Group Title Placebo Aripiprazole 5 mg Aripiprazole 10 mg Aripiprazole 15 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 49 52 59 53
Mean (Standard Error)
Unit of Measure: units on a scale
-8.4  (1.39) -12.4  (1.36) -13.2  (1.25) -14.4  (1.31)
2.Secondary Outcome
Title Mean Clinical Global Impressions Improvement Scale (CGI-I) Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.
Arm/Group Title Placebo Aripiprazole 5 mg Aripiprazole 10 mg Aripiprazole 15 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 49 52 59 53
Mean (Standard Error)
Unit of Measure: units on a scale
3.3  (0.18) 2.6  (0.17) 2.5  (0.16) 2.5  (0.17)
3.Secondary Outcome
Title Number of Participants With Response at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.
Arm/Group Title Placebo Aripiprazole 5 mg Aripiprazole 10 mg Aripiprazole 15 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 49 52 59 53
Measure Type: Number
Unit of Measure: Participants
17 29 29 28
4.Secondary Outcome
Title Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)
Hide 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 decreased in value indicates improvement.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.
Arm/Group Title Placebo Aripiprazole 5 mg Aripiprazole 10 mg Aripiprazole 15 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 44 46 54 48
Mean (Standard Error)
Unit of Measure: units on a scale
-1.7  (0.50) -2.6  (0.50) -2.4  (0.44) -3.2  (0.47)
5.Secondary Outcome
Title Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.
Arm/Group Title Placebo Aripiprazole 5 mg Aripiprazole 10 mg Aripiprazole 15 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 49 52 59 53
Mean (Standard Error)
Unit of Measure: units on a scale
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)
6.Secondary Outcome
Title Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.
Arm/Group Title Placebo Aripiprazole 5 mg Aripiprazole 10 mg Aripiprazole 15 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 41 44 52 44
Mean (Standard Error)
Unit of Measure: units on a scale
-0.6  (0.16) -0.9  (0.15) -1.0  (0.13) -1.1  (0.15)
7.Secondary Outcome
Title Summary of Safety
Hide Description Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation
Time Frame continuously throughout the study
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population=all randomized participants minus 1 patients in the placebo group (no longer met study criteria), and 1 participant in the 5-mg group who withdrew consent.
Arm/Group Title Placebo Aripiprazole 5 mg Aripiprazole 10 mg Aripiprazole 15 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 51 52 59 54
Measure Type: Number
Unit of Measure: participants
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
8.Secondary Outcome
Title Change From Baseline in Body Weight
Hide Description Adjusted mean change (Week 8 - baseline) in body weight
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population=all randomized participants minus 3 patients in the placebo group (1 no longer met study criteria, 2 did not have measurement at baseline and Week 8), and 1 participant in the 5-mg group who withdrew consent. Data set is LOCF.
Arm/Group Title Placebo Aripiprazole 5 mg Aripiprazole 10 mg Aripiprazole 15 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 49 52 59 53
Mean (Standard Error)
Unit of Measure: kilograms
0.3  (0.32) 1.3  (0.31) 1.3  (0.29) 1.5  (0.30)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aripiprazole 10 mg Aripiprazole 15 mg Aripiprazole 5 mg Placebo
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Aripiprazole 10 mg Aripiprazole 15 mg Aripiprazole 5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole 10 mg Aripiprazole 15 mg Aripiprazole 5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/59 (1.69%)   0/54 (0.00%)   1/52 (1.92%)   0/51 (0.00%) 
Nervous system disorders         
PRESYNCOPE  1  0/59 (0.00%)  0/54 (0.00%)  1/52 (1.92%)  0/51 (0.00%) 
Psychiatric disorders         
AGGRESSION  1  1/59 (1.69%)  0/54 (0.00%)  0/52 (0.00%)  0/51 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aripiprazole 10 mg Aripiprazole 15 mg Aripiprazole 5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   51/59 (86.44%)   42/54 (77.78%)   37/52 (71.15%)   31/51 (60.78%) 
Gastrointestinal disorders         
NAUSEA  1  3/59 (5.08%)  4/54 (7.41%)  1/52 (1.92%)  1/51 (1.96%) 
VOMITING  1  12/59 (20.34%)  5/54 (9.26%)  5/52 (9.62%)  4/51 (7.84%) 
DIARRHOEA  1  5/59 (8.47%)  5/54 (9.26%)  2/52 (3.85%)  4/51 (7.84%) 
CONSTIPATION  1  6/59 (10.17%)  3/54 (5.56%)  2/52 (3.85%)  3/51 (5.88%) 
ABDOMINAL PAIN UPPER  1  1/59 (1.69%)  4/54 (7.41%)  2/52 (3.85%)  1/51 (1.96%) 
SALIVARY HYPERSECRETION  1  4/59 (6.78%)  6/54 (11.11%)  1/52 (1.92%)  1/51 (1.96%) 
General disorders         
THIRST  1  1/59 (1.69%)  1/54 (1.85%)  3/52 (5.77%)  1/51 (1.96%) 
FATIGUE  1  13/59 (22.03%)  10/54 (18.52%)  2/52 (3.85%)  0/51 (0.00%) 
PYREXIA  1  7/59 (11.86%)  5/54 (9.26%)  3/52 (5.77%)  0/51 (0.00%) 
Immune system disorders         
SEASONAL ALLERGY  1  0/59 (0.00%)  1/54 (1.85%)  0/52 (0.00%)  4/51 (7.84%) 
Infections and infestations         
NASOPHARYNGITIS  1  5/59 (8.47%)  5/54 (9.26%)  6/52 (11.54%)  2/51 (3.92%) 
GASTROENTERITIS VIRAL  1  3/59 (5.08%)  1/54 (1.85%)  1/52 (1.92%)  0/51 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  0/59 (0.00%)  3/54 (5.56%)  2/52 (3.85%)  0/51 (0.00%) 
Investigations         
WEIGHT INCREASED  1  1/59 (1.69%)  2/54 (3.70%)  4/52 (7.69%)  1/51 (1.96%) 
Metabolism and nutrition disorders         
DECREASED APPETITE  1  5/59 (8.47%)  3/54 (5.56%)  5/52 (9.62%)  1/51 (1.96%) 
INCREASED APPETITE  1  3/59 (5.08%)  7/54 (12.96%)  10/52 (19.23%)  2/51 (3.92%) 
Nervous system disorders         
TREMOR  1  7/59 (11.86%)  6/54 (11.11%)  4/52 (7.69%)  0/51 (0.00%) 
DROOLING  1  8/59 (13.56%)  5/54 (9.26%)  2/52 (3.85%)  0/51 (0.00%) 
HEADACHE  1  5/59 (8.47%)  5/54 (9.26%)  3/52 (5.77%)  2/51 (3.92%) 
LETHARGY  1  3/59 (5.08%)  3/54 (5.56%)  4/52 (7.69%)  0/51 (0.00%) 
SEDATION  1  17/59 (28.81%)  13/54 (24.07%)  9/52 (17.31%)  3/51 (5.88%) 
AKATHISIA  1  2/59 (3.39%)  0/54 (0.00%)  1/52 (1.92%)  3/51 (5.88%) 
SOMNOLENCE  1  5/59 (8.47%)  5/54 (9.26%)  4/52 (7.69%)  2/51 (3.92%) 
HYPERSOMNIA  1  0/59 (0.00%)  2/54 (3.70%)  3/52 (5.77%)  0/51 (0.00%) 
EXTRAPYRAMIDAL DISORDER  1  4/59 (6.78%)  6/54 (11.11%)  2/52 (3.85%)  0/51 (0.00%) 
PSYCHOMOTOR HYPERACTIVITY  1  0/59 (0.00%)  0/54 (0.00%)  3/52 (5.77%)  2/51 (3.92%) 
Psychiatric disorders         
INSOMNIA  1  5/59 (8.47%)  2/54 (3.70%)  1/52 (1.92%)  6/51 (11.76%) 
AGGRESSION  1  2/59 (3.39%)  0/54 (0.00%)  2/52 (3.85%)  3/51 (5.88%) 
Renal and urinary disorders         
ENURESIS  1  1/59 (1.69%)  3/54 (5.56%)  0/52 (0.00%)  1/51 (1.96%) 
Respiratory, thoracic and mediastinal disorders         
COUGH  1  4/59 (6.78%)  0/54 (0.00%)  8/52 (15.38%)  2/51 (3.92%) 
EPISTAXIS  1  4/59 (6.78%)  1/54 (1.85%)  0/52 (0.00%)  0/51 (0.00%) 
RHINORRHOEA  1  5/59 (8.47%)  1/54 (1.85%)  2/52 (3.85%)  1/51 (1.96%) 
NASAL CONGESTION  1  1/59 (1.69%)  4/54 (7.41%)  1/52 (1.92%)  1/51 (1.96%) 
PHARYNGOLARYNGEAL PAIN  1  1/59 (1.69%)  1/54 (1.85%)  1/52 (1.92%)  3/51 (5.88%) 
Skin and subcutaneous tissue disorders         
RASH  1  3/59 (5.08%)  1/54 (1.85%)  0/52 (0.00%)  1/51 (1.96%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11
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.
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.
Results Point of Contact
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00337571     History of Changes
Other Study ID Numbers: CN138-179
First Submitted: June 13, 2006
First Posted: June 16, 2006
Results First Submitted: June 3, 2009
Results First Posted: July 23, 2009
Last Update Posted: December 2, 2013