FMRI Brain Activation of Aripiprazole Treatment in Autism Spectrum Disorders (AripfMRI)
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|ClinicalTrials.gov Identifier: NCT01028820|
Recruitment Status : Completed
First Posted : December 9, 2009
Results First Posted : March 11, 2014
Last Update Posted : March 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Drug: Aripiprazole||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of the Effect of Aripiprazole Treatment in Autism Spectrum Disorders on Functional Magnetic Resonance Imaging (fMRI) Activation Patterns and Symptoms|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
Experimental: Open-Label, Flexible-Dose Aripiprazole
This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.
8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily
Other Name: Abilify
- Baseline and Week 8scores on Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version [ Time Frame: Baseline ("Pre-Dose") to 8 Weeks ("Post-Dose") ]The Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version (CY-BOCS-PDD) is a clinician-rated interview designed to evaluate repetitive behavior in children with pervasive developmental disorders (PDDs). It is a modification of the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), developed to assess typically-developing children with obsessive compulsive behavior. Because of language limitations in children with PDDs the CY-BOCS—PDD only includes the five compulsion items: Time Spent, Interference, Distress, Resistance of repetitive behavior, and Control of repetitive behavior. Each item is rated from 0 (none) through 4 (extreme), and scores can range from 0 to 20, with higher scores reflecting more severe symptoms. Usually a score > than 8 is considered clinically significant.
- Total Repetitive Behavior Scale - Revised (RBS_R) [ Time Frame: baseline week 0, 8 weeks ]
The RBS-R is an assessment that includes Sameness, Self-Injurious Behavior, Ritualistic, Compulsive, and Restrictive Behavior subscales. The assessments are completed by caregivers for the past week, with consideration of frequency,ease of redirecting and extent to which behavior interferes with functioning compared to a typically developing child of the same age and gender. Scores are rated from 0 - behavior does not occur to 3 - behavior occurs and is a serious problem. There are 43 items and 5 subscales. Higher scores indicate greater symptom severity. total score is the sum of all items in all subscales.
The subscales are stereotyped behaviors 6 items, self-injurious behaviors 8 items, Compulsive behaviors- 8 items, Ritualistic Behaviors 6 items, Sameness 11 items, restricted behaviors 4 items.Total score ranges from 0 to 129.
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): NCT01028820
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Linmarie Sikich, MD||University of North Carolina|
|Principal Investigator:||Gabriel Dichter, PhD||University of North Carolina and Duke University|
|Study Director:||Cheryl O Alderman, BS||University of North Carolina, Chapel Hill|