An fMRI Study of the Effect of Intravenous Oxytocin vs. Placebo on Response Inhibition and Face Processing in Autism
Recruitment status was Recruiting
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| First Received Date ICMJE | December 7, 2005 | ||||||||
| Last Updated Date | April 18, 2007 | ||||||||
| Start Date ICMJE | March 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00263796 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | An fMRI Study of the Effect of Intravenous Oxytocin vs. Placebo on Response Inhibition and Face Processing in Autism | ||||||||
| Official Title ICMJE | An fMRI Study of the Effect of Intravenous Oxytocin vs. Placebo on Response Inhibition and Face Processing in Autism | ||||||||
| Brief Summary | To study the effect of oxytocin on face processing and response inhibition in autistic adults by fMRI. |
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| Detailed Description | Autism is a developmental disorder affecting approximately 60/10,000 individuals. It is characterized by social and language deficits and repetitive behaviors/restricted interests. Functional imaging is becoming a very useful tool in trying to understand the neurobiology of autism. Oxytocin is a hormone produced by the brain to assist with labor and lactation. Recent evidence suggests that it may be involved in social attachment and in repetitive behaviors. In this project, we will study how oxytocin changes the way the brain of autistic adults processes faces, and deals with response inhibition (the ability to interrupt ongoing responses should they prove ineffective or interfering with attaining a goal). There is currently no functional imaging data assessing the effect of oxytocin on the brain. We will explore the activation patterns in response to oxytocin across circuits involved in social cognition (face fusiform area) and response inhibition (caudate, orbitofrontal and dorsolateral cortex) by administering a specific fMRI task activating those circuits before and during an oxytocin infusion. We will also explore the effect of oxytocin in these areas by administering specific cognitive testing not associated with fMRI before and during oxytocin infusion. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Autism | ||||||||
| Intervention ICMJE | Drug: Oxytocin | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 30 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00263796 | ||||||||
| Other Study ID Numbers ICMJE | GCO # 04-0749 (2) | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Mount Sinai School of Medicine | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Mount Sinai School of Medicine | ||||||||
| Verification Date | April 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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