Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders

October 5, 2012 updated by: Gabriel Dichter, University of North Carolina, Chapel Hill
The purpose of this proof of concept study is to use functional magnetic resonance imaging and behavioral assessments to investigate the effect of citalopram on restricted repetitive behaviors in people with autism spectrum disorders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27759
        • UNC-Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ambulatory status (outpatient) at time of consent
  • Age 10-55 years
  • Clinical diagnosis of Autism Spectrum Disorder
  • IQ greater than or equal to 70
  • Score greater than 8 on Children's Yale-Brown Obsessive Compulsive Scale
  • 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]

Exclusion Criteria:

  • Age less than 10 years or greater than 55 years, at time of consent
  • Estimated IQ < 70
  • Uncontrolled epilepsy (seizure within 6 months prior to consent)
  • 4. 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 (as verified by testing prior to both initial dose administration of citalopram or placebo and prior to magnetic resonance imaging) due to the risk that may be associated with SSRI treatment and magnetic resonance imaging on fetal health
  • Medical contraindications to SSRI therapy as determined by history (including induction of mania or hypomania during SSRI therapy, or known drug allergy)
  • Concomitant medication that would interfere with study participation
  • Prior history of citalopram treatment failure at appropriate doses and duration
  • Prior history of treatment failure to two previous SSRI trials at appropriate doses and duration
  • Ongoing need for psychoactive medication other than study medication [excepting stable doses (greater than three months duration) of anticonvulsant medication for seizure disorder, or diphenhydramine (Benadryl®)for sleep]

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
Individuals with an Autism Spectrum Disorder receiving citalopram
Drug: Citalopram
Pill, 5-20mg once a day for twelve weeks
Other Names:
  • Celexa
Placebo Comparator: Placebo
Individuals with an Autistic Spectrum Disorder receiving placebo
Drug: Placebo
Placebo pill once a day for twelve weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional Magnetic Resonance Imaging
Time Frame: two 2-hr scans
two 2-hr scans
Clinicians Global Improvement Scale
Time Frame: Upon study completion
Upon study completion

Secondary Outcome Measures

Outcome Measure
Time Frame
Childrens Yale-Brown Obsessive Compulsive Scale
Time Frame: Baseline, wks 2, 4, 8, endpoint
Baseline, wks 2, 4, 8, endpoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Gabriel S Dichter, PhD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

February 6, 2008

First Posted (Estimate)

February 7, 2008

Study Record Updates

Last Update Posted (Estimate)

October 8, 2012

Last Update Submitted That Met QC Criteria

October 5, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-0975
  • K23MH081285 (U.S. NIH Grant/Contract)
  • NIH/NCRR K12 RR023248
  • The Dana Foundation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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