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Brain Imaging Study of Adults With Autism Spectrum Disorders

Primary Purpose

Autism Spectrum Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Vasopressin
Sponsored by
National Institute of Mental Health (NIMH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Autism Spectrum Disorders focused on measuring Oxytocin, Vasopressin, Autism, Amygdala, Social Cognition, Autism Spectrum Disorders, ASD, Healthy Volunteer, HV

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers
  • INCLUSION CRITERIA:

Healthy Controls:

Age between 18 years and 40 years.

Blood Pressure (BP) less than 140/90

Normal EKG.

Menstrual phase: Female participants will be tested only during the follicular phase of their menstrual cycle (defined as days 6-12 after the first day of the last menstrual period).

Patients:

A diagnosis of autism, Asperger s disorder, or PPD NOS.

IQ > 80.

Age between 18 years and 40 years.

Blood Pressure (BP) less than 140/90

Normal EKG.

Menstrual phase: Female participants will be tested only during the follicular phase of their menstrual cycle (defined as days 6-12 after the first day of the last menstrual period).

EXCLUSION CRITERIA:

Healthy Controls:

Impaired hearing.

Head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma.

Having a known risk from exposure to high magnetic fields (e.g. participants with pace makers) or having metallic implants (e.g. braces) in the head region (likely to create artifact on the MRI scans).

Past or present psychiatric, neurological, or severe chronic medical illness. This includes the absence of substance abuse histories, learning disabilities and all DSM IV disorders. The investigators will evaluate medical histories. Potential subjects with medical conditions that are judged not to interfere with the study may be allowed to participate.

Use of medications or drugs that would interfere with study results. This includes contraceptive hormones, steroids, medications for psychiatric symptoms like anxiety or depression, stimulants, and medications for high blood pressure. Participants will be asked to tell the investigators of any medications or drugs that they are taking. The investigators will consider the drug interactions with oxytocin and vasopressin prior to study, and participants will not be able to participate in the study if the drug interactions could be dangerous.

Pregnancy or Nursing Status: Because of the risk to an unborn fetus or infant, women who are pregnant or nursing are excluded from this protocol. Therefore, all women of childbearing potential will have a pregnancy test performed no more than 24 hours before each drug administration and will not be able to participate if the pregnancy test is positive.

Patients:

Impaired hearing.

Head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma.

Having a known risk from exposure to high magnetic fields (e.g. participants with pace makers) or having metallic implants (e.g. braces) in the head region (likely to create artifact on the MRI scans).

A known neurological or neurogenetic condition, such as uncontrolled epilepsy, cerebral palsy, and chromosomal abnormalities.

Use of medications or drugs that would interfere with the study results (see above).

Pregnancy or Nursing Status: Because of the risk to an unborn fetus or infant, women who are pregnant or nursing are excluded from this protocol. Therefore, all women of childbearing potential will have a pregnancy test performed no more than 24 hours before each drug administration and will not be able to participate if the pregnancy test is positive.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Changes in brain activations

Secondary Outcome Measures

Performance scores and reaction time on behavioral tasks

Full Information

First Posted
March 25, 2010
Last Updated
December 14, 2019
Sponsor
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01093768
Brief Title
Brain Imaging Study of Adults With Autism Spectrum Disorders
Official Title
Effects of Prosocial Neuropeptides on Human Brain Function in Healthy Volunteers and Individuals With Autism Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 11, 2013
Overall Recruitment Status
Completed
Study Start Date
February 19, 2010 (undefined)
Primary Completion Date
April 11, 2013 (Actual)
Study Completion Date
April 11, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief Summary
This research study investigates the effects of oxytocin and vasopressin on brain activity in adults with Autism Spectrum Disorders using functional magnetic resonance imaging (fMRI). Background: - Oxytocin and vasopressin are two hormones produced in the brain. Both hormones can influence activity in brain regions such as the amygdala that are involved in social and emotional processing. There is evidence suggesting that oxytocin and vasopressin may be implicated in autism spectrum disorders (ASD). Objectives: -Here, we use functional magnetic resonance imaging (fMRI) to assess the effects of oxytocin and vasopressin on brain activity in adult healthy volunteers and adults with ASD. Eligibility: - Right-handed individuals between 18 and 40 years of age who either have been diagnosed with autism, Asperger s disorder, or Pervasive Developmental Disorder- Not Otherwise Specified (PDD-NOS), or are healthy volunteers. Design: This study requires 3 outpatient visits to the NIH Clinical Center in addition to a screening visit. Each visit will last about 2.5 hours. Participants may not smoke cigarettes or drink alcohol or caffeinated beverages for 12 hours before each visit. During each visit, participants will receive a nasal spray that contains one of the following: oxytocin, vasopressin, or placebo. Participants will receive a different spray at each visit. After using the nasal spray, participants will have an MRI scan of the brain while performing tasks with social and emotional stimuli. After the MRI scan, participants will complete questionnaires about mood and reaction to the tasks, and will remain in the clinic until the effects of the study medication have worn off. Participants will be contacted 1 day after each MRI scan for follow-up purposes.
Detailed Description
Objective: The goal of this protocol, broadly stated, is to evaluate the effects of the neuropeptides oxytocin and vasopressin on the neural systems involved in social cognition and emotional processing in healthy volunteers and individuals with autism spectrum disorders (ASD). Study population: The research participants will be adult healthy volunteers and adults with ASD (ages 18-40 years). Design: This will be a double-blind cross-over functional magnetic resonance imaging (fMRI) study, requiring three visits in addition to a screening visit. At each visit, participants will receive an intranasal application of oxytocin, vasopressin, or placebo and will be scanned while performing social cognition tasks and tasks involving the processing of affective stimuli. Drug order will be randomized across participants in each group (healthy controls and individuals with ASD). Outcome measures: The outcome measures will include both performance scores and reaction times (RTs) on the behavioral tasks and changes in blood oxygenation level-dependent (BOLD) activation in the brain, in both healthy volunteers and patients with ASD. Our main brain region of interest will be the amygdala.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders
Keywords
Oxytocin, Vasopressin, Autism, Amygdala, Social Cognition, Autism Spectrum Disorders, ASD, Healthy Volunteer, HV

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Type
Drug
Intervention Name(s)
Vasopressin
Primary Outcome Measure Information:
Title
Changes in brain activations
Time Frame
1.5 hours
Secondary Outcome Measure Information:
Title
Performance scores and reaction time on behavioral tasks
Time Frame
1.5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: Healthy Controls: Age between 18 years and 40 years. Blood Pressure (BP) less than 140/90 Normal EKG. Menstrual phase: Female participants will be tested only during the follicular phase of their menstrual cycle (defined as days 6-12 after the first day of the last menstrual period). Patients: A diagnosis of autism, Asperger s disorder, or PPD NOS. IQ > 80. Age between 18 years and 40 years. Blood Pressure (BP) less than 140/90 Normal EKG. Menstrual phase: Female participants will be tested only during the follicular phase of their menstrual cycle (defined as days 6-12 after the first day of the last menstrual period). EXCLUSION CRITERIA: Healthy Controls: Impaired hearing. Head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma. Having a known risk from exposure to high magnetic fields (e.g. participants with pace makers) or having metallic implants (e.g. braces) in the head region (likely to create artifact on the MRI scans). Past or present psychiatric, neurological, or severe chronic medical illness. This includes the absence of substance abuse histories, learning disabilities and all DSM IV disorders. The investigators will evaluate medical histories. Potential subjects with medical conditions that are judged not to interfere with the study may be allowed to participate. Use of medications or drugs that would interfere with study results. This includes contraceptive hormones, steroids, medications for psychiatric symptoms like anxiety or depression, stimulants, and medications for high blood pressure. Participants will be asked to tell the investigators of any medications or drugs that they are taking. The investigators will consider the drug interactions with oxytocin and vasopressin prior to study, and participants will not be able to participate in the study if the drug interactions could be dangerous. Pregnancy or Nursing Status: Because of the risk to an unborn fetus or infant, women who are pregnant or nursing are excluded from this protocol. Therefore, all women of childbearing potential will have a pregnancy test performed no more than 24 hours before each drug administration and will not be able to participate if the pregnancy test is positive. Patients: Impaired hearing. Head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma. Having a known risk from exposure to high magnetic fields (e.g. participants with pace makers) or having metallic implants (e.g. braces) in the head region (likely to create artifact on the MRI scans). A known neurological or neurogenetic condition, such as uncontrolled epilepsy, cerebral palsy, and chromosomal abnormalities. Use of medications or drugs that would interfere with the study results (see above). Pregnancy or Nursing Status: Because of the risk to an unborn fetus or infant, women who are pregnant or nursing are excluded from this protocol. Therefore, all women of childbearing potential will have a pregnancy test performed no more than 24 hours before each drug administration and will not be able to participate if the pregnancy test is positive.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan E Swedo, M.D.
Organizational Affiliation
National Institute of Mental Health (NIMH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7990957
Citation
Adolphs R, Tranel D, Damasio H, Damasio A. Impaired recognition of emotion in facial expressions following bilateral damage to the human amygdala. Nature. 1994 Dec 15;372(6507):669-72. doi: 10.1038/372669a0.
Results Reference
background
PubMed Identifier
8853957
Citation
Barberis C, Tribollet E. Vasopressin and oxytocin receptors in the central nervous system. Crit Rev Neurobiol. 1996;10(1):119-54. doi: 10.1615/critrevneurobiol.v10.i1.60.
Results Reference
background
PubMed Identifier
18655901
Citation
Bartz JA, Hollander E. Oxytocin and experimental therapeutics in autism spectrum disorders. Prog Brain Res. 2008;170:451-62. doi: 10.1016/S0079-6123(08)00435-4.
Results Reference
background

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Brain Imaging Study of Adults With Autism Spectrum Disorders

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