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

Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Autism Spectrum Disorders

Intervention: Citalopram (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: University of North Carolina, Chapel Hill

Official(s) and/or principal investigator(s):
Gabriel S Dichter, PhD, Principal Investigator, Affiliation: 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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Primary outcome:

Functional Magnetic Resonance Imaging

Clinicians Global Improvement Scale

Secondary outcome: Childrens Yale-Brown Obsessive Compulsive Scale


Minimum age: 10 Years. Maximum age: 55 Years. Gender(s): Both.


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


- 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]

Locations and Contacts

UNC-Chapel Hill, Chapel Hill, North Carolina 27759, United States
Additional Information

Study Information

Starting date: January 2007
Last updated: October 5, 2012

Page last updated: August 23, 2015

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