The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Bartz, Jennifer, Ph.D..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Bartz, Jennifer, Ph.D.
Information provided by:
Bartz, Jennifer, Ph.D.
ClinicalTrials.gov Identifier:
NCT01183221
First received: August 12, 2010
Last updated: August 13, 2010
Last verified: August 2010
| Tracking Information | |||||
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| First Received Date ICMJE | August 12, 2010 | ||||
| Last Updated Date | August 13, 2010 | ||||
| Start Date ICMJE | June 2010 | ||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01183221 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 | The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders | ||||
| Official Title ICMJE | The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders | ||||
| Brief Summary | This study examines the effects of oxytocin on complex social cognition in adults with autism spectrum disorders. Participants receive a one-time administration of intranasal oxytocin (or placebo) and perform an empathic accuracy task, a novel and ecologically valid measure of complex social cognition, in conjunction with functional magnetic resonance imaging (fMRI). We will investigate the effects of oxytocin (versus placebo) on the behavioral and neural correlates of empathic accuracy. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Syntocinon
One dose of 24 IU (3 sprays/nostril) |
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| Study Arm (s) | Experimental: placebo spray
Intervention: Drug: Syntocinon |
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| 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 | ||||
| Estimated Enrollment ICMJE | 35 | ||||
| Estimated Completion Date | August 2011 | ||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01183221 | ||||
| Other Study ID Numbers ICMJE | 09-0857 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Jennifer Bartz, Ph.D., Mount Sinai School of Medicine | ||||
| Study Sponsor ICMJE | Bartz, Jennifer, Ph.D. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Bartz, Jennifer, Ph.D. | ||||
| Verification Date | August 2010 | ||||
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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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