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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
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Fragile X Syndrome
Intervention: Drug: Aripiprazole

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Open-label Aripiprazole Twelve subjects received open-label aripiprazole, mean final dose was 9.8 mg /day.

Participant Flow:   Overall Study
    Open-label Aripiprazole
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Open-label Aripiprazole Twelve subjects received open-label aripiprazole for 12 weeks. Mean dose, 9.8 mg/day

Baseline Measures
   Open-label Aripiprazole 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      10  83.3% 
Between 18 and 65 years      2  16.7% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Full Range)
 14.3 
 (6 to 25) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  16.7% 
Male      10  83.3% 
Region of Enrollment 
[Units: Participants]
 
United States   12 
Aberrant Behavior Checklist [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 
ABC Irritability S   25.3  (5.1) 
ABC Hyperactivity   31.8  (5.8) 
ABC Social Withdrawal   16.6  (11.8) 
ABC Stereotypy   12.7  (5.6) 
ABC Inappropriate Speech   6.8  (5.1) 
[1] 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 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.5  (0.5) 
[1] 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.
Children's Yale-Brown Obsessive Compulsive Scale Modified for PDD [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 14.2  (4.6) 
[1] 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 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 124.5  (26.7) 
[1] 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


  Outcome Measures

1.  Primary:   Aberrant Behavior Checklist   [ Time Frame: Obtained at Baseline and Week 12 ]

2.  Primary:   Clinical Global Impressions- Severity   [ Time Frame: Obtained at Baseline and Week 12 ]

3.  Secondary:   The Children's Yale-Brown Obsessive Compulsive Scale   [ Time Frame: Obtained at Baseline and Week 12 ]

4.  Secondary:   Social Responsiveness Scale   [ Time Frame: Obtained at Baseline and Week 12 ]

5.  Secondary:   The Vineland Adaptive Behavior Scales   [ Time Frame: Screen Visit ]

6.  Secondary:   The Vineland Maladaptive Behavior Subscales   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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: Craig Erickson
Organization: Cincinnati Childrens Hospital
phone: 5136366265
e-mail: craig.erickson@cchmc.org


Publications:

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00420459     History of Changes
Other Study ID Numbers: 0609-22
First Submitted: January 9, 2007
First Posted: January 11, 2007
Results First Submitted: July 29, 2015
Results First Posted: April 18, 2017
Last Update Posted: April 18, 2017