Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders
This study has been completed.
Sponsor:
University of North Carolina, Chapel Hill
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
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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
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 Mental Disorders Diagnosed in Childhood Mental Disorders Citalopram Dexetimide Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |
ClinicalTrials.gov processed this record on May 16, 2013