FMRI Brain Activation of Aripiprazole Treatment in Autism Spectrum Disorders
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Intervention: Aripiprazole
Intervention description: 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily
Intervention MeSH terms: Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 10 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: autism; asperger's; repetitive; restricted; compulsions

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