FMRI Brain Activation of Aripiprazole Treatment in Autism Spectrum Disorders

Autism Spectrum Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028820
• Other study ID #: 090795
• Secondary ID: K23MH081285
• Status: Completed
• Phase: Phase 4
• First received: December 4, 2009
• Last updated: February 7, 2014
• Start date: August 2009
• Est. completion date: January 2011

Study information

• Verified date: February 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Drug:
• Aripiprazole
8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Duke University, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline ("Pre-Dose") to 8 Weeks ("Post-Dose")	No
Secondary	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.	baseline week 0, 8 weeks	No