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

Study Overview
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Brief Summary
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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.

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

Conditions
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Autism Spectrum Disorders

Intervention / Treatment
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* Drug: Citalopram
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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]

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Restricted repetitive behaviors, restricted interests, Aspergers, Autism