Clinical trial NCT01028820: FMRI Brain Activation of Aripiprazole Treatment in Autism Spectrum Disorders
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Autism Spectrum Disorder
Keywords: autism
asperger's
repetitive
restricted
compulsions
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Duke University
name: National Institute of Mental Health (NIMH)
First posted: 2009-12-09
Enrollment: 13
Sex: ALL
Minimum age (years): 10
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Baseline and Week 8scores on Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version
timeFrame: Baseline ("Pre-Dose") to 8 Weeks ("Post-Dose")
Secondary outcomes:
measure: Total Repetitive Behavior Scale - Revised (RBS_R)
timeFrame: baseline week 0, 8 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Linmarie Sikich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina and Duke University
name: Gabriel Dichter, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Cheryl O Alderman, BS
role: STUDY_DIRECTOR
References: