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An Open-Label Trial of Aripiprazole in Autism Spectrum Disorders

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ClinicalTrials.gov Identifier: NCT00308074
Recruitment Status : Completed
First Posted : March 29, 2006
Results First Posted : January 2, 2017
Last Update Posted : February 15, 2017
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Jean Frazier, Cambridge Health Alliance

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Autism
Asperger's Disorder
Pervasive Developmental Disorder
Intervention Drug: Aripiprazole
Enrollment 14
Recruitment Details Recruitment will take place from mainly the Cambridge Health Alliance clinics, and the McLean Hospital affiliated service site for children and adolescents with an autism spectrum disorder (ASD), but also from other healthcare facilities in the vicinity.
Pre-assignment Details All individuals enrolled will have Diagnostic and Statistical Manual Fourth Edition (DSM-IV) diagnoses of Autism, Asperger’s Disorder or Pervasive Developmental Disorder, not otherwise specified (PDD NOS) and will be enrolled in this 12-week open-label study
Arm/Group Title Aripiprazole
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aripiprazole monotherapy

Aripiprazole will be started at 2.5 or 5mg depending on clinical impression and severity of aggression and agitation. The dose will be evaluated weekly, according to clinical impression and adjusted if deemed appropriate, in not more than 5mg increments . The lowest effective dose will be used.

Period Title: Overall Study
Started 14
Completed 13
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Aripiprazole
Hide Arm/Group Description aripiprazole monotherapy
Overall Number of Baseline Participants 14
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[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
14
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
13  (1.66)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
5
  35.7%
Male
9
  64.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title Clinical Global Impressions-Improvement
Hide Description The Clinical Global Impression – Improvement scale (CGI-I) is a 7 point scale that requires the clinician to evaluate how much the patient's illness has improved or worsened compared to their baseline condition at the beginning of the intervention. The ratings are evaluated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Time Frame Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole
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aripiprazole monotherapy
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.8  (1.6)
2.Primary Outcome
Title Aberrant Behavior Checklist-Irritability Subscale
Hide Description

Aberrant Behavior Checklist (ABC) The ABC is a 58 item symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. Items are rated on a 4-point scale (0=no problem to 3=severe problem). A decrease in score indicates improvement.

There are five subscales: a) Irritability and Agitation b) Lethargy and Social Withdrawal c) Stereotypic Behavior d) Hyperactivity and Noncompliance and e) Inappropriate Speech.This study uses the Irritability subscale for its outcome. The Irritability subscale is the sum of 15 items. Each item is rated using the scale: 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The Irritability subscale total score ranges from 0 to 45. A decrease in score over time indicates improvement.

Time Frame Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole
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aripiprazole monotherapy
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline irritability score 24.5  (10.5)
Endpoint irritability score 8  (7.9)
3.Secondary Outcome
Title Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Hide Description 10-item assessment of obsessive-compulsive symptoms in patients less than 18 years of age. There are 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale ( from 0=no symptoms/minimum severity, to 4=extreme symptoms/maximum severity). Total is the sum of 10 items. The range of possible totals is 0 (no symptoms) to 40 (severe). A decrease in value indicates improvement.
Time Frame Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole
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aripiprazole monotherapy
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline score 15.9  (9.5)
Endpoint score 9.9  (6.9)
4.Secondary Outcome
Title Brief Psychiatric Rating Scale for Children (BPRS-C)
Hide Description The Brief Psychiatric Rating Scale for Children is a 21-item rating scale to evaluate psychiatric problems based on the clinician’ s interview with the child/adolescent and parents. It has 7 scales: behavioral problems, depression, thought disorders, psychomotor excitation, withdrawal-retardation, anxiety, organicity. Ratings are based on a 7 point scale, from "Not Present" (scores 0) to "Extremely Severe" (scores 6 points). Total is the sum of the 21 items. The range of possible totals is 0 (no symptoms) to 126 (extremely severe).A decrease in score indicates improvement.
Time Frame Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole
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aripiprazole monotherapy
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline score 69.0  (17.4)
Endpoint score 36.1  (14.9)
Time Frame 2 years, 10 months
Adverse Event Reporting Description Labs, vital signs, ECG and the MOSES were collected at scheduled intervals.
 
Arm/Group Title Aripiprazole
Hide Arm/Group Description aripiprazole monotherapy
All-Cause Mortality
Aripiprazole
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole
Affected / at Risk (%) # Events
Total   0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aripiprazole
Affected / at Risk (%) # Events
Total   1/14 (7.14%)    
Blood and lymphatic system disorders   
neutropenia  [1]  1/14 (7.14%)  1
Indicates events were collected by systematic assessment
[1]
Baseline -10 yo male no physical complaints; nausea,vomiting reported later in day. Baseline labs included WBC of 3500µl;absolute neutrophil 560. Study drug delayed for add'tl evaluation. Repeat CBC week later,results normal and throughout the trial.
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: Dr. Jean A. Frazier
Organization: University of Massachusetts Medical School
Phone: 508-856-5896
Responsible Party: Jean Frazier, Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT00308074     History of Changes
Other Study ID Numbers: CHA-IRB-0119/06/05
First Submitted: March 28, 2006
First Posted: March 29, 2006
Results First Submitted: March 11, 2015
Results First Posted: January 2, 2017
Last Update Posted: February 15, 2017