The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01183221
Recruitment Status : Unknown
Verified August 2010 by Bartz, Jennifer, Ph.D..
Recruitment status was:  Recruiting
First Posted : August 17, 2010
Last Update Posted : August 17, 2010
Information provided by:
Bartz, Jennifer, Ph.D.

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.

Condition or disease Intervention/treatment Phase
Autism ASD Drug: Syntocinon Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
Study Start Date : June 2010
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: placebo spray Drug: Syntocinon
One dose of 24 IU (3 sprays/nostril)

Primary Outcome Measures :
  1. Empathic accuracy performance [ Time Frame: 45 minutes after drug/placebo administration ]
  2. fmri BOLD response during empathic accuracy task [ Time Frame: 45 minutes after oxytocin/placebo administration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01183221

Contact: Jessica Zweifach, M.S.T. 212.241.2826

United States, New York
Mount Sinai School of Medicine - Seaver Autism Center for Research and Treatment Recruiting
New York, New York, United States, 10029
Contact: Jessica Zweifach, M.S.T.    212-241-2826   
Principal Investigator: Jennifer Bartz, P.h.D.         
Sponsors and Collaborators
Bartz, Jennifer, Ph.D.
Principal Investigator: Jennifer Bartz, P.h.D. Icahn School of Medicine at Mount Sinai

Responsible Party: Jennifer Bartz, Ph.D., Mount Sinai School of Medicine Identifier: NCT01183221     History of Changes
Other Study ID Numbers: 09-0857
First Posted: August 17, 2010    Key Record Dates
Last Update Posted: August 17, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Reproductive Control Agents
Physiological Effects of Drugs