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

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: NCT00263796
Recruitment Status : Completed
First Posted : December 9, 2005
Last Update Posted : April 30, 2014
Information provided by (Responsible Party):
Evdokia Anagnostou, Icahn School of Medicine at Mount Sinai

Brief Summary:
To study the effect of oxytocin on face processing and response inhibition in autistic adults by fMRI.

Condition or disease Intervention/treatment Phase
Autism Drug: Oxytocin Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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
Study Start Date : March 2006
Actual Primary Completion Date : October 2010
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

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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

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): NCT00263796

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United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574
Sponsors and Collaborators
Anagnostou, Evdokia, M.D.
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Principal Investigator: Evdokia Anagnostou, MD Icahn School of Medicine at Mount Sinai
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Responsible Party: Evdokia Anagnostou, Adjunct Assistant Professor, Icahn School of Medicine at Mount Sinai Identifier: NCT00263796    
Other Study ID Numbers: GCO # 04-0749 (2)
First Posted: December 9, 2005    Key Record Dates
Last Update Posted: April 30, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Reproductive Control Agents
Physiological Effects of Drugs