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

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

Tracking Information
First Submitted Date  ICMJE December 7, 2005
First Posted Date  ICMJE December 9, 2005
Last Update Posted Date April 30, 2014
Study Start Date  ICMJE March 2006
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2014)
Change in BOLD with oxytocin infusion [ Time Frame: baseline and 4 hours ]
Change in BOLD with oxytocin infusion BOLD - blood-oxygen-level-dependent contrast
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An fMRI Study of the Effect of Intravenous Oxytocin vs. Placebo on Response Inhibition and Face Processing in Autism
Official Title  ICMJE An fMRI Study of the Effect of Intravenous Oxytocin vs. Placebo on Response Inhibition and Face Processing in Autism
Brief Summary To study the effect of oxytocin on face processing and response inhibition in autistic adults by fMRI.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Autism
Intervention  ICMJE
  • Drug: Oxytocin
    10 international units = 1 cc, IV over 4 hours
    Other Name: Pitocin
  • Drug: Placebo
    Normal Saline, IV over 4 hours
Study Arms  ICMJE
  • Experimental: Pitocin
    Intervention: Drug: Oxytocin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2014)
16
Original Enrollment  ICMJE
 (submitted: December 8, 2005)
30
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00263796
Other Study ID Numbers  ICMJE GCO # 04-0749 (2)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Evdokia Anagnostou, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Anagnostou, Evdokia, M.D.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Evdokia Anagnostou, MD Icahn School of Medicine at Mount Sinai
PRS Account Anagnostou, Evdokia, M.D.
Verification Date April 2014

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