Clinical Trial: A Prospective Open-label Study of Aripiprazole in Fragile X Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Aripiprazole in Fragile X Syndrome

Brief Summary: The purpose of this study is to determine the effectiveness and tolerability of aripiprazole in the treatment of children and adolescents with Fragile X Syndrome.

Detailed Summary:

This 12-week prospective, open-label study design was chosen to gather pilot data for potential future lager scale, double-blind, placebo-controlled studies in Fragile X Syndrome.

We hypothesize that aripiprazole will be effective in decreasing aggression, SIB, agitation, and interfering repetitive behavior commonly observed in individuals with Fragile X Syndrome. We also hypothesize that aripiprazole will be well tolerated.

Current Primary Outcome:

• Aberrant Behavior Checklist [ Time Frame: Obtained at Baseline and Week 12 ]
  The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. The ABC has 5 subscales: Social Withdrawal (16 items) ranging from 0 (not at all) to 48 (severe), Irritability (15 items) ranging from 0 (not at all) to 45 (severe), Inappropriate Speech (4 items) ranging from 0 (not at all) to 12 (severe), Hyperactivity (16 items) ranging from 0 (not at all) to 48 (severe), and Stereotypy (7 items) ranging from 0 (not at all) to 21 (severe). Items are rated from 0 (not at all) to 3 (severe).
• Clinical Global Impressions- Severity [ Time Frame: Obtained at Baseline and Week 12 ]
  The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.

Original Primary Outcome:

• Parent-rated irritability subscale of Aberrant Behavior Checklist (ABC)
• Clinician-rated Clinical Global Impression (CGI)- global improvement item (CGI-I)

Current Secondary Outcome:

• The Children's Yale-Brown Obsessive Compulsive Scale [ Time Frame: Obtained at Baseline and Week 12 ]
  The CY-BOCS PDD has been utilized in a largescale clinical treatment study of repetitive behavior in idiopathic ASDs. CYBOCS-PDD scores range from 0 to 20 and measure repetitive/compulsive behavior and not obsessions. Higher score indicate worse outcome.
• Social Responsiveness Scale [ Time Frame: Obtained at Baseline and Week 12 ]
  The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows: 0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment
• The Vineland Adaptive Behavior Scales [ Time Frame: Screen Visit ]
  Vineland Adaptive Behavior Scales are a valid and reliable test to measure a person's adaptive level of functioning. Vineland-II forms aid in diagnosing and classifying intellectual and developmental disabilities and other disorders, such as autism spectrum disorders and developmental delays. The content and scales are organized within a 4 domain structure: Communication, Daily Living, Socialization and Motor Skills. The adaptive behavior composite standard score is computed from the sum of standard scores from the domains and converted into the adaptive behavior composite standard score. Higher scores indicate a higher adaptive level of functioning.
• The Vineland Maladaptive Behavior Subscales [ Time Frame: Week 12 ]
  The Vineland Adaptive Behavior Scales include an optional Maladaptive Behavior Index with 27 items. The Maladaptive Behavior Index is a composite of Internalizing, Externalizing, and other types of undesirable behavior that may interfere with the individual's adaptive functioning. The Maladaptive Behavior subscale yields raw scores (0-27).

Original Secondary Outcome:

Information By: Indiana University

Dates:
Date Received: January 9, 2007
Date Started: April 2007
Date Completion:
Last Updated: March 29, 2017
Last Verified: March 2017