FMRI Brain Activation of Aripiprazole Treatment in Autism Spectrum Disorders (AripfMRI)
This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill
First received: December 4, 2009
Last updated: February 7, 2014
Last verified: February 2014
This is an 8 week research study of aripiprazole (abilify) which is used to reduce irritable behaviors in autism spectrum disorders. All participants will receive active study medication. Participants will also receive diagnostic and cognitive evaluations at no cost. Participants will be required to undergo two fMRI (functional magnetic resonance imaging scans) where we will take pictures of your brain while performing simple tasks.
Autism Spectrum Disorder
||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Pilot Study of the Effect of Aripiprazole Treatment in Autism Spectrum Disorders on Functional Magnetic Resonance Imaging (fMRI) Activation Patterns and Symptoms
Primary Outcome Measures:
- 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") ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
- Total Repetitive Behavior Scale - Revised (RBS_R) [ Time Frame: baseline week 0, 8 weeks ] [ Designated as safety issue: No ]
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2011 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||10 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- male or female of any race or ethnicity
- ambulatory status (outpatient) at time of consent
- age 10-55 inclusive at time of consent
- clinical diagnosis of autism spectrum disorder and meets screening criteria on the Social Communication Questionnaire as well as either the Autism Diagnostic Observation Schedule (ADOS) or the Autism Diagnostic Interview-Revised (ADI-R) administered by raters trained to research reliability.
- estimated IQ greater than 70 and capable of making an informed decision based on assessment of their understanding and judgment
- Children's Yale-Brown Obsessive Compulsive Scale: Modified for Pervasive Developmental Disorders (PDD-CYBOCS) > 8 as assessed during telephone screening.
- Free of psychoactive medication for at least: one month for fluoxetine; two weeks for other SSRIs and neuroleptics; and five days for stimulants prior to MRI scanning [excepting stable doses (greater than three months duration) of anticonvulsant medication for seizure disorder]
- Currently taking psychoactive medication that is not providing sufficient relief of repetitive behaviors and willing to discontinue all psychoactive medication for the duration of the study.
- Judged reliable for medication compliance and agreeing to keep follow-up study appointments.
- Age less than 10 years or greater than 55 years at time of consent
- Estimated IQ less than 70
- Uncontrolled epilepsy (seizure within 6 months prior to consent)
- Presence of medical conditions that might interfere with participation, or where participation would be contraindicated.
- History of neurological injury: head trauma, poorly-controlled seizure disorder (seizure within the preceding six months), stroke, prior neurosurgery, or under the care of a neurologist or neurosurgeon as determined by interview
- History of claustrophobia
- Implanted or irremovable metal in the body (including certain tattoos and permanent make-up).
- Current pregnancy in females
- Inability to communicate satisfactorily and directly (without a translator) in English
- Medical contraindications to aripiprazole therapy as determined by history (including induction of neuroleptic malignant syndrome, dystonic reaction, or known drug allergy)
- Ongoing need for psychoactive medication other than study medication [excepting stable doses (greater than 3 months duration) of anticonvulsant medication for seizure disorder or diphenhydramine for sleep
- prior history of aripiprazole treatment failure at appropriate doses and duration
- clinically significant low white blood cell count at baseline
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028820
|University of North Carolina
|Chapel Hill, North Carolina, United States, 27599 |
|Duke University Medical Center
|Durham, North Carolina, United States, 27705 |
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
||Linmarie Sikich, MD
||University of North Carolina
||Gabriel Dichter, PhD
||University of North Carolina and Duke University
||Cheryl O Alderman, BS
||University of North Carolina, Chapel Hill
||Linmarie Sikich, MD, Associate Professor of Psychiatry, University of North Carolina, Chapel Hill
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 4, 2009
|Results First Received:
||November 7, 2012
||February 7, 2014
||United States: Institutional Review Board
Keywords provided by University of North Carolina, Chapel Hill:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 03, 2016
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Central Nervous System Agents
Central Nervous System Depressants
Physiological Effects of Drugs