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Autism Spectrum DisordersPhase 1NCT01093768

Brain Imaging Study of Adults With Autism Spectrum Disorders

A Phase 1 study testing Oxytocin and Vasopressin in people with Autism Spectrum Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorders
What is being tested?
Oxytocin and Vasopressin
How many people
38 participants
Where
1 siteUnited States
Study dates
19 Feb 2010to 11 Apr 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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:
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  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Effects of Prosocial Neuropeptides on Human Brain Function in Healthy Volunteers and Individuals With Autism Spectrum Disorders

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:

Read more
  • 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.
Read the 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.

Being tested
Oxytocin, Vasopressin
Keywords
Oxytocin, Vasopressin, Autism, Amygdala, Social Cognition, Autism Spectrum Disorders, ASD, Healthy Volunteer, HV
Medical subject headings
Autism Spectrum Disorder, Diabetes Insipidus, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in brain activations

    Measured: 1.5 hours

Secondary outcomes (1)

  1. Performance scores and reaction time on behavioral tasks

    Measured: 1.5 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2010 (estimated)
  2. Study start19 Feb 2010
  3. Primary completion11 Apr 2013
  4. Study completion11 Apr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01093768
Sponsor's protocol ID
100068
Other IDs
10-M-0068
Status last verified
11 Apr 2013
First submitted
25 Mar 2010
Last updated
17 Dec 2019
Results posted
No

Publications

  • 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.

    PubMed 7990957

  • 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.

    PubMed 8853957

  • 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.

    PubMed 18655901

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oxytocin and Vasopressin in people with Autism Spectrum Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in brain activations (time frame: 1.5 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01093768, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.

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