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
Information provided by:
Bartz, Jennifer, Ph.D.
First received: August 12, 2010
Last updated: August 13, 2010
Last verified: August 2010
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.
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
||The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
Primary Outcome Measures:
- Empathic accuracy performance [ Time Frame: 45 minutes after drug/placebo administration ] [ Designated as safety issue: No ]
- fmri BOLD response during empathic accuracy task [ Time Frame: 45 minutes after oxytocin/placebo administration ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2011 (Final data collection date for primary outcome measure)
Experimental: placebo spray
One dose of 24 IU (3 sprays/nostril)
|Ages Eligible for Study:
||18 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- In good physical health
- Meet criteria for ASD according to psychiatric interview using the Diagnostic and Statistic Manual, Fourth Edition (DSM-IV)
- Must be a history of developmental delay
- Must meet full criteria for ASD on the Autism Diagnostic Interview- Revised (ADI-R) on either the social or communication domains and within two points on other domain (only if parent available for interview)
- Must meet full criteria for ASD on the Autism Diagnostic Observation Schedule- Generic (ADOS-G) on the social domain. Meeting for ASD on the communication domain and total domain is not necessary
- Must have a verbal IQ greater than 75, as measured by the Wechsler Adult Intelligence Scale- Fourth Edition (WAIS- III). Intelligence testing performed at other sites or through another protocol at this site within the past year will also be accepted
- Capability of performing experimental tasks (i.e. can read and understand task instructions, cooperate with procedures)
- Informed consent and capacity
- Female participants must remain on birth control for the duration of the study
- Participants with any primary psychiatric diagnosis at screening
- Participants with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal MRI/structural lesion of the brain
- Participants who are pregnant, who gave birth in the last six months, or who are currently breastfeeding
- Participants with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being
- Participants with evidence or history of malignancy or any significant hematological endocrine, cardiovascular (including rhythm disorder), respiratory, renal, hepatic, gastrointestinal disease, or other major medical conditions
- Participants taking psychoactive medication(s) (e.g., stimulants, antidepressants, antipsychotics, antiepileptics, anxiolytics, clondine)
- Participants who, in the Investigator's opinion, might not be suitable for the study
- Participants who are involved in another study whose procedures could influence performance in the current study
- Female participants who do not stay on birth control for the duration of the study
- Participants who have a known contraindication to the MRI scan: including sever claustrophobia or any kind of metal implant in the body
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183221
|Contact: Jessica Zweifach, M.S.T.
|Mount Sinai School of Medicine - Seaver Autism Center for Research and Treatment
|New York, New York, United States, 10029 |
|Contact: Jessica Zweifach, M.S.T. 212-241-2826 firstname.lastname@example.org |
|Principal Investigator: Jennifer Bartz, P.h.D. |
Bartz, Jennifer, Ph.D.
||Jennifer Bartz, P.h.D.
||Mount Sinai School of Medicine
No publications provided
ClinicalTrials.gov processed this record on February 27, 2015
||Jennifer Bartz, Ph.D., Mount Sinai School of Medicine
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 12, 2010
||August 13, 2010
||United States: Food and Drug Administration