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

• ClinicalTrials.gov Identifier: NCT00609531
• Recruitment Status: Completed
• First Posted: February 7, 2008
• Last Update Posted: October 8, 2012
• Sponsor: University of North Carolina, Chapel Hill
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Gabriel Dichter, University of North Carolina, Chapel Hill

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Autism Spectrum Disorders	Drug: Citalopram; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• 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
• Study Start Date: January 2007
• Actual Primary Completion Date: August 2009
• Actual Study Completion Date: August 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• 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

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

• 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 Posted: February 7, 2008
• Last Update Posted: October 8, 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; Dexetimide; Citalopram; 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