An Open-Label Trial of Aripiprazole in Autism Spectrum Disorders
|Autism Asperger's Disorder Pervasive Developmental Disorder||Drug: Aripiprazole||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Open-Label Trial of Aripiprazole Monotherapy in the Autism Spectrum Disorders (ASD)|
- Clinical Global Impressions-Improvement [ Time Frame: Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13. ]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.
- Aberrant Behavior Checklist-Irritability Subscale [ Time Frame: Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13. ]
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.
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13. ]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.
- Brief Psychiatric Rating Scale for Children (BPRS-C) [ Time Frame: Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13. ]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.
|Study Start Date:||February 2006|
|Study Completion Date:||February 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
aripiprazole monotherapy, begun at 2.5 mg or 5.0 mg based on clinical impression and severity of aggression and agitation. Dose to be adjusted in not more than 5 mg increments, weekly. The lowest effective dose will be used up to a maximum daily dose of 20 mg.
Other Name: Abilify
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00308074
|United States, Massachusetts|
|Cambridge Health Alliance|
|Medford, Massachusetts, United States, 02155|
|Principal Investigator:||Jean A Frazier, MD||Cambridge Health Alliance|