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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gabriel Dichter, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00609531
First received: January 24, 2008
Last updated: October 5, 2012
Last verified: October 2012

January 24, 2008
October 5, 2012
January 2007
August 2009   (final data collection date for primary outcome measure)
  • Functional Magnetic Resonance Imaging [ Time Frame: two 2-hr scans ] [ Designated as safety issue: No ]
  • Clinicians Global Improvement Scale [ Time Frame: Upon study completion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00609531 on ClinicalTrials.gov Archive Site
Childrens Yale-Brown Obsessive Compulsive Scale [ Time Frame: Baseline, wks 2, 4, 8, endpoint ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders
Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Autism Spectrum Disorders
  • Drug: Citalopram
    Pill, 5-20mg once a day for twelve weeks
    Other Name: Celexa
  • Drug: Placebo
    Placebo pill once a day for twelve weeks
  • Experimental: Active
    Individuals with an Autism Spectrum Disorder receiving citalopram
    Intervention: Drug: Citalopram
  • Placebo Comparator: Placebo
    Individuals with an Autistic Spectrum Disorder receiving placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
August 2009
August 2009   (final data collection date for primary outcome measure)

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]
Both
10 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00609531
04-0975, NIH/NCRR K12 RR023248, The Dana Foundation, K23MH081285
No
Gabriel Dichter, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Principal Investigator: Gabriel S Dichter, PhD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP