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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.
Sponsor:
Information provided by (Responsible Party):
Evdokia Anagnostou, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00263796
First received: December 7, 2005
Last updated: April 28, 2014
Last verified: April 2014
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

Drug Information available for: Oxytocin
U.S. FDA Resources

Further study details as provided by Anagnostou, Evdokia, M.D.:

Primary Outcome Measures:
  • Change in BOLD with oxytocin infusion [ Time Frame: baseline and 4 hours ] [ Designated as safety issue: No ]
    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.

  Eligibility
Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT00263796

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

No publications provided

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

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

ClinicalTrials.gov processed this record on August 20, 2015