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

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT00609531

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jan 1, 2007

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Aug 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Functional Magnetic Resonance Imaging [two 2-hr scans]
Clinicians Global Improvement Scale [Upon study completion]

Secondary Outcome Measures

Childrens Yale-Brown Obsessive Compulsive Scale [Baseline, wks 2, 4, 8, endpoint]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)
1. 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]