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An fMRI Study of the Effect of Intravenous Oxytocin vs. Placebo on Response Inhibition and Face Processing in Autism

This study has been completed.
Information provided by (Responsible Party):
Evdokia Anagnostou, Mount Sinai School of Medicine Identifier:
First received: December 7, 2005
Last updated: April 28, 2014
Last verified: April 2014
To study the effect of oxytocin on face processing and response inhibition in autistic adults by fMRI.

Condition Intervention Phase
Autism Drug: Oxytocin Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An fMRI Study of the Effect of Intravenous Oxytocin vs. Placebo on Response Inhibition and Face Processing in Autism

Resource links provided by NLM:

Further study details as provided by Evdokia Anagnostou, Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Change in BOLD with oxytocin infusion [ Time Frame: baseline and 4 hours ]
    Change in BOLD with oxytocin infusion BOLD - blood-oxygen-level-dependent contrast

Enrollment: 16
Study Start Date: March 2006
Study Completion Date: September 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pitocin Drug: Oxytocin
10 international units = 1 cc, IV over 4 hours
Other Name: Pitocin
Placebo Comparator: Placebo Drug: Placebo
Normal Saline, IV over 4 hours

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.

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Meet DSM-IV, ADI, or ADOS criteria for autism spectrum disorder.
  2. Age 18-50.
  3. Be seen as outpatients
  4. IQ>80
  5. 5. Demonstrate capacity to provide authorized informed consent or provide consent for participation by an approved surrogate on the autistic individual's behalf

Exclusion Criteria:

  1. Subjects who are pregnant or nursing mothers. Sexually active women of childbearing potential who are not using adequate birth control measures.
  2. Subjects with epilepsy.
  3. Subjects with a history of schizophrenia, schizoaffective disorder or other Axis 1 mental disorders, such as bipolar disorder.
  4. Subjects reporting history of encephalitis, phenylketonuria, tuberous sclerosis, fragile X syndrome, anoxia during birth, neurofibromatosis, hypomelanosis, hypothyroidism, Duchenne muscular dystrophy, and maternal rubella
  5. Subjects who have received depot neuroleptic medication, or other psychoactive drugs within the past 5 weeks.
  6. Subjects with renal or liver disease or abnormalities in blood chemistry.
  7. Any metallic prosthesis such as plates, pins and screws, shrapnel, metallic foreign body, vascular or neurosurgical clips that may be incompatible with the MRI and any electrical devices such as a pacemaker or a defibrillator
  8. Claustrophobia
  Contacts and Locations
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Please refer to this study by its identifier: NCT00263796

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574
Sponsors and Collaborators
Anagnostou, Evdokia, M.D.
Principal Investigator: Evdokia Anagnostou, MD Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Evdokia Anagnostou, Adjunct Assistant Professor, Mount Sinai School of Medicine Identifier: NCT00263796     History of Changes
Other Study ID Numbers: GCO # 04-0749 (2)
Study First Received: December 7, 2005
Last Updated: April 28, 2014

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Reproductive Control Agents
Physiological Effects of Drugs processed this record on September 21, 2017