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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

December 7, 2005
April 28, 2014
March 2006
October 2010   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00263796 on ClinicalTrials.gov Archive Site
Not Provided
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An fMRI Study of the Effect of Intravenous Oxytocin vs. Placebo on Response Inhibition and Face Processing in Autism
An fMRI Study of the Effect of Intravenous Oxytocin vs. Placebo on Response Inhibition and Face Processing in Autism

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Autism
  • Drug: Oxytocin
    10 international units = 1 cc, IV over 4 hours
    Other Name: Pitocin
  • Drug: Placebo
    Normal Saline, IV over 4 hours
  • Experimental: Pitocin
    Intervention: Drug: Oxytocin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
September 2012
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00263796
GCO # 04-0749 (2)
Yes
Evdokia Anagnostou, Mount Sinai School of Medicine
Anagnostou, Evdokia, M.D.
Not Provided
Principal Investigator: Evdokia Anagnostou, MD Mount Sinai School of Medicine
Anagnostou, Evdokia, M.D.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP