Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders
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ClinicalTrials.gov Identifier: NCT00609531 |
Recruitment Status :
Completed
First Posted : February 7, 2008
Last Update Posted : October 8, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Autism Spectrum Disorders | Drug: Citalopram Drug: Placebo | Phase 1 |
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 |

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
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Drug: Placebo
Placebo pill once a day for twelve weeks |
- Functional Magnetic Resonance Imaging [ Time Frame: two 2-hr scans ]
- Clinicians Global Improvement Scale [ Time Frame: Upon study completion ]
- Childrens Yale-Brown Obsessive Compulsive Scale [ Time Frame: Baseline, wks 2, 4, 8, endpoint ]

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Ages Eligible for Study: | 10 Years to 55 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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]

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
United States, North Carolina | |
UNC-Chapel Hill | |
Chapel Hill, North Carolina, United States, 27759 |
Principal Investigator: | Gabriel S Dichter, PhD | University of North Carolina, Chapel Hill |
Responsible Party: | Gabriel Dichter, Associate Professor of Psychiatry, University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00609531 |
Other Study ID Numbers: |
04-0975 NIH/NCRR K12 RR023248 The Dana Foundation K23MH081285 ( U.S. NIH Grant/Contract ) |
First Posted: | February 7, 2008 Key Record Dates |
Last Update Posted: | October 8, 2012 |
Last Verified: | October 2012 |
Restricted repetitive behaviors restricted interests Aspergers Autism |
Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders 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 |