search
Back to results

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

Primary Purpose

Autism

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo
Sponsored by
Anagnostou, Evdokia, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meet DSM-IV, ADI, or ADOS criteria for autism spectrum disorder. Age 18-50. Be seen as outpatients IQ>80 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: Subjects who are pregnant or nursing mothers. Sexually active women of childbearing potential who are not using adequate birth control measures. Subjects with epilepsy. Subjects with a history of schizophrenia, schizoaffective disorder or other Axis 1 mental disorders, such as bipolar disorder. Subjects reporting history of encephalitis, phenylketonuria, tuberous sclerosis, fragile X syndrome, anoxia during birth, neurofibromatosis, hypomelanosis, hypothyroidism, Duchenne muscular dystrophy, and maternal rubella Subjects who have received depot neuroleptic medication, or other psychoactive drugs within the past 5 weeks. Subjects with renal or liver disease or abnormalities in blood chemistry. 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 Claustrophobia

Sites / Locations

  • Mount Sinai School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pitocin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in BOLD with oxytocin infusion
Change in BOLD with oxytocin infusion BOLD - blood-oxygen-level-dependent contrast

Secondary Outcome Measures

Full Information

First Posted
December 7, 2005
Last Updated
April 28, 2014
Sponsor
Anagnostou, Evdokia, M.D.
search

1. Study Identification

Unique Protocol Identification Number
NCT00263796
Brief Title
An fMRI Study of the Effect of Intravenous Oxytocin vs. Placebo on Response Inhibition and Face Processing in Autism
Official Title
An fMRI Study of the Effect of Intravenous Oxytocin vs. Placebo on Response Inhibition and Face Processing in Autism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anagnostou, Evdokia, M.D.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pitocin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
10 international units = 1 cc, IV over 4 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal Saline, IV over 4 hours
Primary Outcome Measure Information:
Title
Change in BOLD with oxytocin infusion
Description
Change in BOLD with oxytocin infusion BOLD - blood-oxygen-level-dependent contrast
Time Frame
baseline and 4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet DSM-IV, ADI, or ADOS criteria for autism spectrum disorder. Age 18-50. Be seen as outpatients IQ>80 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: Subjects who are pregnant or nursing mothers. Sexually active women of childbearing potential who are not using adequate birth control measures. Subjects with epilepsy. Subjects with a history of schizophrenia, schizoaffective disorder or other Axis 1 mental disorders, such as bipolar disorder. Subjects reporting history of encephalitis, phenylketonuria, tuberous sclerosis, fragile X syndrome, anoxia during birth, neurofibromatosis, hypomelanosis, hypothyroidism, Duchenne muscular dystrophy, and maternal rubella Subjects who have received depot neuroleptic medication, or other psychoactive drugs within the past 5 weeks. Subjects with renal or liver disease or abnormalities in blood chemistry. 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 Claustrophobia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evdokia Anagnostou, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs