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

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ClinicalTrials.gov Identifier: NCT00609531
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : October 8, 2012
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Gabriel Dichter, University of North Carolina, Chapel Hill

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Drug: Citalopram Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders
Study Start Date : January 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

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Arms and Interventions
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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 Name: Celexa
Placebo Comparator: Placebo
Individuals with an Autistic Spectrum Disorder receiving placebo
 Drug: Placebo
Placebo pill once a day for twelve weeks


Outcome Measures
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Primary Outcome Measures :
  1. Functional Magnetic Resonance Imaging [ Time Frame: two 2-hr scans ]
  2. Clinicians Global Improvement Scale [ Time Frame: Upon study completion ]

Secondary Outcome Measures :
  1. Childrens Yale-Brown Obsessive Compulsive Scale [ Time Frame: Baseline, wks 2, 4, 8, endpoint ]

Eligibility Criteria
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Ages Eligible for Study:   10 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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]
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00609531


Locations
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United States, North Carolina
UNC-Chapel Hill
Chapel Hill, North Carolina, United States, 27759
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Gabriel S Dichter, PhD University of North Carolina, Chapel Hill
More Information
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Responsible Party: Gabriel Dichter, Associate Professor of Psychiatry, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00609531    
Other Study ID Numbers: 04-0975
NIH/NCRR K12 RR023248
The Dana Foundation
K23MH081285 ( U.S. NIH Grant/Contract )
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: October 8, 2012
Last Verified: October 2012
Keywords provided by Gabriel Dichter, University of North Carolina, Chapel Hill:
Restricted repetitive behaviors
restricted interests
Aspergers
Autism
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs