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Trial record 33 of 535 for:    ESCITALOPRAM AND Disorders

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00609531
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : October 8, 2012
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Gabriel Dichter, University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE January 24, 2008
First Posted Date  ICMJE February 7, 2008
Last Update Posted Date October 8, 2012
Study Start Date  ICMJE January 2007
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2008)
  • Functional Magnetic Resonance Imaging [ Time Frame: two 2-hr scans ]
  • Clinicians Global Improvement Scale [ Time Frame: Upon study completion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00609531 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2008)
Childrens Yale-Brown Obsessive Compulsive Scale [ Time Frame: Baseline, wks 2, 4, 8, endpoint ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders
Official Title  ICMJE Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Condition  ICMJE Autism Spectrum Disorders
Intervention  ICMJE
  • Drug: Citalopram
    Pill, 5-20mg once a day for twelve weeks
    Other Name: Celexa
  • Drug: Placebo
    Placebo pill once a day for twelve weeks
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2012)
12
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2008)
40
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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]
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00609531
Other Study ID Numbers  ICMJE 04-0975
NIH/NCRR K12 RR023248
The Dana Foundation
K23MH081285 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gabriel Dichter, University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Gabriel S Dichter, PhD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date October 2012

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