Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders - Full Text View

Sponsor:	The University of North Carolina, Chapel Hill
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00609531

Purpose

The purpose of this 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
Autism Spectrum Disorders	Drug: Citalopram Drug: Placebo

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

Resource links provided by NLM:

MedlinePlus related topics: Autism MRI Scans

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by The 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 ]

Estimated Enrollment:	40
Study Start Date:	January 2007
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Experimental Individuals with an Autism Spectrum Disorder receiving citalopram	Drug: Citalopram Pill, 5-20mg once a day for twelve weeks
Placebo: Placebo Comparator 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

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

The University of North Carolina, Chapel Hill

Investigators

Principal Investigator:

Gabriel S Dichter, PhD

The University of North Carolina, Chapel Hill

More Information

Additional Information:

Study Information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of North Carolina at Chapel Hill ( Gabriel Dichter/Principal Investigator )
Study ID Numbers:	04-0975, NIH/NCRR K12 RR023248, The Dana Foundation
Study First Received:	January 24, 2008
Last Updated:	October 16, 2009
ClinicalTrials.gov Identifier:	NCT00609531 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of North Carolina, Chapel Hill:

Restricted repetitive behaviors
restricted interests
Aspergers
Autism

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Child Development Disorders, Pervasive
Pathologic Processes
Mental Disorders
Autistic Disorder

Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Antidepressive Agents, Second-Generation
Dexetimide
Antidepressive Agents
Disease
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010