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Trial record 2 of 53 for:    Developmental Disabilities | ( Map: Indiana, United States )

Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders

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: NCT00870727
Recruitment Status : Completed
First Posted : March 27, 2009
Results First Posted : November 28, 2018
Last Update Posted : January 1, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Bristol-Myers Squibb
Information provided by (Responsible Party):
Indiana University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pervasive Developmental Disorder
Interventions Drug: Aripiprazole oral product
Drug: Placebo oral capsule
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1. Aripiprazole Oral Product Arm 2. Placebo Oral Capsule
Hide Arm/Group Description

Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.

Aripiprazole oral product: Minimum dose of 2mg per day to a maximum of 20 mg per day over 8-weeks of treatment.

Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment.

Placebo oral capsule: Placebo will identical in size and appearance to study drug.

Period Title: Overall Study
Started 17 16
Completed 16 11
Not Completed 1 5
Reason Not Completed
Lost to Follow-up             0             1
Lack of Efficacy             1             3
Adverse Event             0             1
Arm/Group Title Arm 1. Aripiprazole Oral Product Arm 2. Placebo Oral Capsule Total
Hide Arm/Group Description

Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.

Aripiprazole oral product: Minimum dose of 2mg per day to a maximum of 20 mg per day over 8-weeks of treatment.

Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment.

Placebo oral capsule: Placebo will identical in size and appearance to study drug.

Total of all reporting groups
Overall Number of Baseline Participants 17 16 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 16 participants 33 participants
9.8  (3.0) 9.5  (2.3) 9.6  (2.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
Female
2
  11.8%
5
  31.3%
7
  21.2%
Male
15
  88.2%
11
  68.8%
26
  78.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
16
  94.1%
16
 100.0%
32
  97.0%
Unknown or Not Reported
1
   5.9%
0
   0.0%
1
   3.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.9%
3
  18.8%
4
  12.1%
White
15
  88.2%
11
  68.8%
26
  78.8%
More than one race
1
   5.9%
2
  12.5%
3
   9.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 16 participants 33 participants
17 16 33
1.Primary Outcome
Title Number of Participants Improved as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2)
Hide Description Clinical Global Impressions (Guy, 1976) global improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7, with lower scores indicating greater improvement (1=very much improved and 2=much improved). Participants with a CGI-I score of 1 or 2 were classified as improved. Four participants assigned to placebo completed an exit interview prior to week 8. One participant assigned to placebo and one participant assigned to aripiprazole withdrew from the study without completing an exit interview.
Time Frame Double-blind phase study exit - up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized study participants who completed an exit interview
Arm/Group Title Arm 1. Aripiprazole Oral Product Arm 2. Placebo Oral Capsule
Hide Arm/Group Description:

Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.

Aripiprazole oral product: Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.

Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment.

Placebo oral capsule: Placebo will be identical in size and appearance to study drug.

Overall Number of Participants Analyzed 16 15
Measure Type: Number
Unit of Measure: participants
11 3
2.Primary Outcome
Title Mean Post-baseline Aberrant Behavior Checklist Irritability Subscale Score, Parent Report, Double-blind Phase
Hide Description The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Irritability subscale is 0 to 45. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints. Confidence intervals reflect a Bonferroni multiple testing correction accounting for the selection of two primary outcomes.
Time Frame Weeks 1, 2, 3, 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized study participants
Arm/Group Title Arm 1. Aripiprazole Oral Product Arm 2. Placebo Oral Capsule
Hide Arm/Group Description:

Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.

Aripiprazole oral product: Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.

Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment.

Placebo oral capsule: Placebo will be identical in size and appearance to study drug.

Overall Number of Participants Analyzed 17 16
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
18.3
(14.2 to 22.5)
26.4
(22.1 to 30.8)
3.Secondary Outcome
Title Mean Post-baseline Aberrant Behavior Checklist Hyperactivity Subscale Score, Parent Report, Double-blind Phase
Hide Description The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers overactivity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores is 0 to 48 on the Hyperactivity subscale. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints.
Time Frame Weeks 1, 2, 3, 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized study participants
Arm/Group Title Arm 1. Aripiprazole Oral Product Arm 2. Placebo Oral Capsule
Hide Arm/Group Description:

Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.

Aripiprazole oral product: Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.

Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment.

Placebo oral capsule: Placebo will be identical in size and appearance to study drug.

Overall Number of Participants Analyzed 17 16
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
23.8
(19.7 to 28.0)
29.4
(25.2 to 33.8)
4.Secondary Outcome
Title Mean Post-baseline Aberrant Behavior Checklist Inappropriate Speech Subscale Score, Parent Report, Double-blind Phase
Hide Description The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Inappropriate Speech subscale is 0 to 12. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints.
Time Frame Weeks 1, 2, 3, 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized study participants
Arm/Group Title Arm 1. Aripiprazole Oral Product Arm 2. Placebo Oral Capsule
Hide Arm/Group Description:

Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.

Aripiprazole oral product: Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.

Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment.

Placebo oral capsule: Placebo will be identical in size and appearance to study drug.

Overall Number of Participants Analyzed 17 16
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
4.6
(3.8 to 5.4)
6.0
(5.2 to 6.8)
5.Secondary Outcome
Title Mean Post-baseline Aberrant Behavior Checklist Social Withdrawal Subscale Score, Parent Report, Double-blind Phase
Hide Description The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item Parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Social Withdrawal subscale is 0 to 48. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints.
Time Frame Weeks 1, 2, 3, 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized study participants
Arm/Group Title Arm 1. Aripiprazole Oral Product Arm 2. Placebo Oral Capsule
Hide Arm/Group Description:

Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.

Aripiprazole oral product: Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.

Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment.

Placebo oral capsule: Placebo will be identical in size and appearance to study drug.

Overall Number of Participants Analyzed 17 16
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
6.1
(3.4 to 8.7)
9.6
(6.8 to 12.4)
6.Secondary Outcome
Title Mean Post-baseline Aberrant Behavior Checklist Stereotypy Subscale Score, Parent Report, Double-blind Phase
Hide Description The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Stereotypy subscale is 0 to 21. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints.
Time Frame Weeks 1, 2, 3, 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized study participants
Arm/Group Title Arm 1. Aripiprazole Oral Product Arm 2. Placebo Oral Capsule
Hide Arm/Group Description:

Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.

Aripiprazole oral product: Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.

Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment.

Placebo oral capsule: Placebo will be identical in size and appearance to study drug.

Overall Number of Participants Analyzed 17 16
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
3.9
(2.6 to 5.3)
5.3
(3.9 to 6.7)
Time Frame Eight weeks or at the time of latest data collection.
Adverse Event Reporting Description Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
 
Arm/Group Title Arm 1. Aripiprazole Oral Product Arm 2. Placebo Oral Capsule
Hide Arm/Group Description

Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.

Aripiprazole oral product: Minimum dose of 2mg per day to a maximum of 20 mg per day over 8-weeks of treatment.

Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment.

Placebo oral capsule: Placebo will identical in size and appearance to study drug.

All-Cause Mortality
Arm 1. Aripiprazole Oral Product Arm 2. Placebo Oral Capsule
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/16 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1. Aripiprazole Oral Product Arm 2. Placebo Oral Capsule
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1. Aripiprazole Oral Product Arm 2. Placebo Oral Capsule
Affected / at Risk (%) Affected / at Risk (%)
Total   16/17 (94.12%)   13/16 (81.25%) 
Gastrointestinal disorders     
Constipation   1/17 (5.88%)  0/16 (0.00%) 
Diarrhea   1/17 (5.88%)  0/16 (0.00%) 
Flatulence   1/17 (5.88%)  0/16 (0.00%) 
Nausea   1/17 (5.88%)  0/16 (0.00%) 
Stomach or abdominal discomfort   4/17 (23.53%)  3/16 (18.75%) 
Vomiting   0/17 (0.00%)  2/16 (12.50%) 
General disorders     
Appetite decrease   3/17 (17.65%)  0/16 (0.00%) 
Appetite increase   6/17 (35.29%)  2/16 (12.50%) 
Dry mouth   1/17 (5.88%)  0/16 (0.00%) 
Fever   1/17 (5.88%)  1/16 (6.25%) 
Hypersalivation   4/17 (23.53%)  0/16 (0.00%) 
Increased thirst   0/17 (0.00%)  1/16 (6.25%) 
Other Pain   1/17 (5.88%)  0/16 (0.00%) 
Sedation/Drowsiness   3/17 (17.65%)  1/16 (6.25%) 
Tiredness/Fatigue   5/17 (29.41%)  3/16 (18.75%) 
Immune system disorders     
Allergies Not Otherwise Specified   0/17 (0.00%)  1/16 (6.25%) 
Infections and infestations     
Flu or upper respiratory problems   0/17 (0.00%)  2/16 (12.50%) 
Nasal congestion or Cold   2/17 (11.76%)  6/16 (37.50%) 
Sore throat   0/17 (0.00%)  1/16 (6.25%) 
Metabolism and nutrition disorders     
Weight gain   3/17 (17.65%)  1/16 (6.25%) 
Weight loss   1/17 (5.88%)  0/16 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscle/bone/joint pain/condition   1/17 (5.88%)  1/16 (6.25%) 
Nervous system disorders     
Headache   5/17 (29.41%)  5/16 (31.25%) 
Tremor   0/17 (0.00%)  1/16 (6.25%) 
Unspecified or not otherwise listed head   1/17 (5.88%)  0/16 (0.00%) 
Psychiatric disorders     
Anxiety/Nervousness/Worry   0/17 (0.00%)  1/16 (6.25%) 
Change in speech   1/17 (5.88%)  1/16 (6.25%) 
Concentration difficulty   1/17 (5.88%)  0/16 (0.00%) 
Daydreaming   2/17 (11.76%)  0/16 (0.00%) 
Difficulty falling asleep   1/17 (5.88%)  3/16 (18.75%) 
Echolalia   0/17 (0.00%)  1/16 (6.25%) 
Emotional outburst   1/17 (5.88%)  0/16 (0.00%) 
Hypertalkativeness   1/17 (5.88%)  0/16 (0.00%) 
Increased motor activity   2/17 (11.76%)  0/16 (0.00%) 
Interrupted sleep/other sleep problems   2/17 (11.76%)  3/16 (18.75%) 
Irritability   0/17 (0.00%)  5/16 (31.25%) 
Restlessness/Agitation including fidgety   2/17 (11.76%)  0/16 (0.00%) 
Stereotypy   1/17 (5.88%)  0/16 (0.00%) 
Unspecified or not otherwise listed psych   1/17 (5.88%)  0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough   1/17 (5.88%)  1/16 (6.25%) 
Skin and subcutaneous tissue disorders     
Generalized rash   1/17 (5.88%)  0/16 (0.00%) 
Localized rash   1/17 (5.88%)  0/16 (0.00%) 
Vascular disorders     
Intermittent nosebleed   1/17 (5.88%)  0/16 (0.00%) 
Indicates events were collected by systematic assessment
The PI who conducted the trial left the institution, Indiana University, prior to data analysis. The institution negotiated/executed a data transfer agreement for the PI's primary mentor, Dr. Christopher McDougle, to analyze the data on her behalf.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Christopher J. McDougle, MD
Organization: Indiana University
Phone: 781-860-1783
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00870727     History of Changes
Other Study ID Numbers: 0805-26
MH 082119
First Submitted: February 2, 2009
First Posted: March 27, 2009
Results First Submitted: October 31, 2018
Results First Posted: November 28, 2018
Last Update Posted: January 1, 2019