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
  Purpose

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.


Condition Intervention Phase
Autism Spectrum Disorders
Drug: Citalopram
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Childrens Yale-Brown Obsessive Compulsive Scale [ Time Frame: Baseline, wks 2, 4, 8, endpoint ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: January 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Individuals with an Autism Spectrum Disorder receiving citalopram
Drug: Citalopram
Pill, 5-20mg once a day for twelve weeks
Other Name: Celexa
Placebo Comparator: Placebo
Individuals with an Autistic Spectrum Disorder receiving placebo
Drug: Placebo
Placebo pill once a day for twelve weeks

  Eligibility

Ages Eligible for Study:   10 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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]
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609531

Locations
United States, North Carolina
UNC-Chapel Hill
Chapel Hill, North Carolina, United States, 27759
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Gabriel S Dichter, PhD University of North Carolina, Chapel Hill
  More Information

Additional Information:
No publications provided

Responsible Party: Gabriel Dichter, Associate Professor of Psychiatry, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00609531     History of Changes
Other Study ID Numbers: 04-0975, NIH/NCRR K12 RR023248, The Dana Foundation, K23MH081285
Study First Received: January 24, 2008
Last Updated: October 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Restricted repetitive behaviors
restricted interests
Aspergers
Autism

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014