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

University of North Carolina (UNC)

Status and phase: Completed; Phase 4

Conditions: Autism Spectrum Disorder

Treatments: Drug: Aripiprazole

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01028820

090795

K23MH081285 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 10 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Open-Label, Flexible-Dose Aripiprazole

Experimental group

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.

Treatment:

Drug: Aripiprazole