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

Autism Spectrum Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00609531
• Other study ID #: 04-0975
• Secondary ID: NIH/NCRR K12 RR0
• Status: Completed
• Phase: Phase 1
• First received: January 24, 2008
• Last updated: October 5, 2012
• Start date: January 2007
• Est. completion date: August 2009

Study information

• Verified date: October 2012
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 55 Years

Eligibility

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]

Study Design

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

Related Conditions & MeSH terms

• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Drug:
• Citalopram
Pill, 5-20mg once a day for twelve weeks
• Placebo
Placebo pill once a day for twelve weeks

Locations

Country	Name	City	State
United States	UNC-Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Magnetic Resonance Imaging		two 2-hr scans	No
Primary	Clinicians Global Improvement Scale		Upon study completion	No
Secondary	Childrens Yale-Brown Obsessive Compulsive Scale		Baseline, wks 2, 4, 8, endpoint	No

External Links

•   Study Information