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
Sponsor:
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
  Purpose

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 Intervention
Autism
ASD
Drug: Syntocinon

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by Bartz, Jennifer, Ph.D.:

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: 35
Study Start Date: June 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: placebo spray Drug: Syntocinon
One dose of 24 IU (3 sprays/nostril)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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

Locations
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    jessica.zweifach@mssm.edu   
Principal Investigator: Jennifer Bartz, P.h.D.         
Sponsors and Collaborators
Bartz, Jennifer, Ph.D.
Investigators
Principal Investigator: Jennifer Bartz, P.h.D. Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Jennifer Bartz, Ph.D., Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01183221     History of Changes
Other Study ID Numbers: 09-0857
Study First Received: August 12, 2010
Last Updated: August 13, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014