Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders
NCT ID: NCT00609531
Last Updated: 2012-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2007-01-31
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Active
Individuals with an Autism Spectrum Disorder receiving citalopram
Citalopram
Pill, 5-20mg once a day for twelve weeks
Placebo
Individuals with an Autistic Spectrum Disorder receiving placebo
Placebo
Placebo pill once a day for twelve weeks
Interventions
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Citalopram
Pill, 5-20mg once a day for twelve weeks
Placebo
Placebo pill once a day for twelve weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 \[excepting stable doses (greater than three months duration) of anticonvulsant medication for seizure disorder, or diphenhydramine (Benadryl®)for sleep\]
10 Years
55 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Gabriel Dichter
Associate Professor of Psychiatry
Principal Investigators
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Gabriel S Dichter, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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UNC-Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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NIH/NCRR K12 RR023248
Identifier Type: -
Identifier Source: secondary_id
The Dana Foundation
Identifier Type: -
Identifier Source: secondary_id
04-0975
Identifier Type: -
Identifier Source: org_study_id