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

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byGabriel Dichter, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of North Carolina, Chapel Hill

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Cheryl O Alderman, BS

Principal Investigator

University of North Carolina, Chapel Hill

Linmarie Sikich, MD

Principal Investigator

University of North Carolina

Gabriel Dichter, PhD

Principal Investigator

University of North Carolina and Duke University

Eligibility Criteria

Inclusion Criteria

estimated IQ greater than 70 and capable of making an informed decision based on assessment of their understanding and judgment

male or female of any race or ethnicity

ambulatory status (outpatient) at time of consent

See 6 more

Treatment Details

Interventions

Aripiprazole (Atypical Antipsychotic)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Open-Label, Flexible-Dose AripiprazoleExperimental Treatment1 Intervention

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.

Aripiprazole is already approved in Canada, Japan for the following indications: