A Prospective Open-label Study of Aripiprazole in Fragile X Syndrome
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|ClinicalTrials.gov Identifier: NCT00420459|
Recruitment Status : Completed
First Posted : January 11, 2007
Results First Posted : April 18, 2017
Last Update Posted : April 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Fragile X Syndrome||Drug: Aripiprazole||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aripiprazole in Fragile X Syndrome|
|Study Start Date :||April 2007|
|Primary Completion Date :||March 2010|
|Study Completion Date :||March 2010|
U.S. FDA Resources
All subjects will initially receive 2.5 mg/day of aripiprazole during the first week. The dosage may be increased to a maximum of 20 mg/day over 8 weeks.
Other Name: Abilify
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420459
|United States, Indiana|
|Riley Child and Adolescent Psychiatry Clinic - Riley Hospital for Children|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Craig A. Erickson, MD||Indiana University|