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FMRI Brain Activation of Aripiprazole Treatment in Autism Spectrum Disorders (AripfMRI)

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring autism, asperger's, repetitive, restricted, compulsions

Eligibility Criteria

10 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • University of North Carolina
  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-Label, Flexible-Dose Aripiprazole

Arm Description

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.

Outcomes

Primary Outcome Measures

Baseline and Week 8scores on Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version
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)
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.

Full Information

First Posted
December 4, 2009
Last Updated
February 7, 2014
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Duke University, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01028820
Brief Title
FMRI Brain Activation of Aripiprazole Treatment in Autism Spectrum Disorders
Acronym
AripfMRI
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 Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Duke University, National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
autism, asperger's, repetitive, restricted, compulsions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-Label, Flexible-Dose Aripiprazole
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily
Primary Outcome Measure Information:
Title
Baseline and Week 8scores on Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version
Description
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.
Time Frame
Baseline ("Pre-Dose") to 8 Weeks ("Post-Dose")
Secondary Outcome Measure Information:
Title
Total Repetitive Behavior Scale - Revised (RBS_R)
Description
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.
Time Frame
baseline week 0, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linmarie Sikich, MD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gabriel Dichter, PhD
Organizational Affiliation
University of North Carolina and Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cheryl O Alderman, BS
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Study Director
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

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FMRI Brain Activation of Aripiprazole Treatment in Autism Spectrum Disorders

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