Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders
Information source: The University of North Carolina, Chapel Hill
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Autism Spectrum Disorders
Intervention: Citalopram (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of North Carolina Official(s) and/or principal investigator(s):
Gabriel S Dichter, PhD, Principal Investigator, Affiliation: The University of North Carolina, Chapel Hill
Overall contact:
Gabriel Dichter, PhD, Phone: 919-681-3169, Email: dichter@biac.duke.edu
Summary
The purpose of this 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: Other, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
Primary outcome: Functional Magnetic Resonance ImagingClinicians Global Improvement Scale
Secondary outcome: Childrens Yale-Brown Obsessive Compulsive Scale
Eligibility
Minimum age: 10 Years.
Maximum age: 55 Years.
Gender(s): Both.
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]
Locations and Contacts
Gabriel Dichter, PhD, Phone: 919-681-3169, Email: dichter@biac.duke.edu
UNC-Chapel Hill, Chapel Hill, North Carolina 27759, United States; Recruiting
Additional Information
Study Information
Starting date: January 2007
Ending date: June 2013
Last updated: February 6, 2008
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