FMRI Brain Activation of Aripiprazole Treatment in Autism Spectrum Disorders

NCT01028820 | Completed Phase 4 Results

• 2 other identifiers: 090795K23MH081285
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorder

Keywords

autism; asperger's; repetitive; restricted; compulsions

Outcome Measures

Primary Outcomes (1)

• 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")

Secondary Outcomes (1)

• Total Repetitive Behavior Scale - Revised (RBS_R)

  baseline week 0, 8 weeks

Study Arms (1)

Open-Label, Flexible-Dose Aripiprazole

EXPERIMENTAL

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.

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

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

Also known as: Abilify

Open-Label, Flexible-Dose Aripiprazole

Eligibility Criteria

• Age: 10 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Duke University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Compulsive Behavior

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

The present study had 13 subjects. Due to sample size, analysis reflected an exploratory approach. If a mechanism for predicting RRB improvement is found in a study with a larger N, we could better understand therapies targeting core symptoms of ASD.

Results Point of Contact

• Title: Linmarie Sikich, M.D.
• Organization: The University of North Carolina at Chapel Hill

lsikich@med.unc.edu

(919) 972-7499

Study Officials

• Linmarie Sikich, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

• Gabriel Dichter, PhD

  University of North Carolina and Duke University

  PRINCIPAL INVESTIGATOR

• Cheryl O Alderman, BS

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: December 9, 2009
• Study Start: August 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: March 11, 2014
• Results First Posted: March 11, 2014

Record last verified: 2014-02

Locations

US (2)