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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00609531

First Posted: February 7, 2008

Last Update Posted: October 10, 2012

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.

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Gabriel Dichter, University of North Carolina, Chapel Hill

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: Triple (Participant, Care Provider, Investigator)
Official Title:	Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders

Resource links provided by NLM:

Genetics Home Reference related topics: autism spectrum disorder

MedlinePlus related topics: Autism Spectrum Disorder

Drug Information available for: Citalopram hydrobromide Citalopram Escitalopram oxalate

U.S. FDA Resources

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

Primary Outcome Measures:

Functional Magnetic Resonance Imaging [ Time Frame: two 2-hr scans ]
Clinicians Global Improvement Scale [ Time Frame: Upon study completion ]

Secondary Outcome Measures:

Childrens Yale-Brown Obsessive Compulsive Scale [ Time Frame: Baseline, wks 2, 4, 8, endpoint ]


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

Information from the National Library of Medicine

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Ages Eligible for Study:	10 Years to 55 Years (Child, Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Gabriel S Dichter, PhD	University of North Carolina, Chapel Hill

More Information

Additional Information:

Study Information This link exits the ClinicalTrials.gov site


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 ( U.S. NIH Grant/Contract )
First Submitted:	January 24, 2008
First Posted:	February 7, 2008
Last Update Posted:	October 10, 2012
Last Verified:	October 2012

Keywords provided by Gabriel Dichter, University of North Carolina, Chapel Hill:


Restricted repetitive behaviors restricted interests Aspergers Autism

Additional relevant MeSH terms:


Disease Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Pathologic Processes Neurodevelopmental Disorders Mental Disorders Citalopram Dexetimide Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents	Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents

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