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Autism Spectrum DisordersPhase 1NCT01945957

Brain Imaging of Intranasal Oxytocin Treatment in Autism

A Phase 1 study testing Oxytocin in people with Autism Spectrum Disorders, run by University of North Carolina, Chapel Hill 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 is a 4 part study: Phase 1a. -functional magnetic resonance imaging (fMRI) ( with oxytocin 24 IU vs. placebo = oxytocin 0 IU) - funded by grant #U54 HD079124-01, Phase 1b-eye-tracking(oxytocin 24 IU vs. placebo = oxytocin 0 IU), Phase 2a. fMRI (oxytocin 8 IU vs. oxytocin 40IU), Phase 2b. Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Autism Spectrum Disorders
What is being tested?
Oxytocin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
Sep 2014to Jan 2017
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 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Between 6 and 18 years of age, inclusive
  • Have a clinical diagnosis of an autism spectrum disorder confirmed according to the Autism Diagnostic Observation Scale (ADOS, Lord et al., 1989). Diagnosis may also be confirmed using the Autism Diagnostic Interview-Revised (ADI-R).
  • Male or female of any race or ethnicity
  • Ambulatory status (outpatient) at time of assent/consent
  • Estimated IQ greater than or equal to 70 and capable of making an informed decision based on assessment of their understanding and judgment

Who cannot join

  • History of neurological injury: head trauma, poorly-controlled seizure disorder (i.e. seizure within the preceding six month period), stroke, prior neurosurgery, or under the care of a neurologist or neurosurgeon as determined by interview
  • History of claustrophobia
  • Implanted medical devices, implanted metal debris, shrapnel, certain tattoos, or permanent makeup that is contraindicated for MRI. Participants fill out a detailed questionnaire on the day of scanning to identify potential MRI risks
  • Subjects with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. This includes, but is not limited to: Rett Syndrome, impairment of renal function, evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder or uncontrolled hypertension), respiratory, hepatic, or gastrointestinal disease
  • Marked sensory impairment such as deafness or blindness that would interfere with the conduct of the study
  • Pregnant or nursing because of the unknown effects of oxytocin to unborn babies and/or nursing infants. All females of child-bearing potential will be administered a serum pregnancy test at screening and at any point during the study at physician discretion. Refusal to undergo a pregnancy test will result in exclusion from the study. We will share results of a pregnancy test with the subject's legal guardian.
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  • Refusal to do pregnancy testing with understanding that guardian will be informed of positive test results
  • Inability or refusal of sexually active female subjects (who have begun menses) to utilize two medically accepted barrier forms of birth control
  • Use of hormonal birth control
  • Subjects who have a history of an anaphylactic reaction from prior treatment with oxytocin (nasal spray)
  • Inability of caretakers to speak English
  • Absence of a consistent caretaker to report on symptoms
  • Subjects who, in the Investigator's opinion, might not be suitable for the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27517

Other trials in United States

About this study

Official title: Brain Imaging and Eye-tracking in Response to Intranasal Oxytocin Treatment in Children and Adolescents With Autism

This is a 4 part study:

Phase 1a. -functional magnetic resonance imaging (fMRI) ( with oxytocin 24 IU vs. placebo = oxytocin 0 IU) - funded by grant #U54 HD079124-01, Phase 1b-eye-tracking(oxytocin 24 IU vs. placebo = oxytocin 0 IU), Phase 2a. fMRI (oxytocin 8 IU vs. oxytocin 40IU), Phase 2b. -eye-tracking (oxytocin 8IU vs. oxytocin 40IU). Time course of effect will also be assessed within session.

Read the detailed description

We hypothesize that intranasal oxytocin treatment (OT) of individuals with an autism spectrum disorder (ASD) will:

Hypothesis 1a. will produce greater increases in Ventral Tegmental Area (VTA) and Nucleus Accumbens (NAc) activation during social reward anticipation compared to placebo, providing evidence that OT increases activation in brain regions critical for social motivation. (NICHD funding for this section/aim- Dr. Joe Piven -U54 HD079124-01)

Hypothesis 1b. will spend proportionally more time attending to the social image on a screen vs. the non-social image compared to placebo.

Hypothesis 2a. will produce differential effects in VTA and NAc activation during social reward anticipation compared with the oxytocin 8 IU vs. oxytocin 40 IU dose, providing evidence that OT dose-dependently increases activation in brain regions critical for social motivation.

Hypothesis 2b. will differentially attend to the social image on a screen vs. the non-social image compared in the oxytocin 8 IU vs. oxytocin 40 IU dose, providing evidence that OT dose-dependently changes the value of social stimuli.

Being tested
Oxytocin
Keywords
autism, brain, functional magnetic resonance imaging, oxytocin
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder

What participants receive

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

  • OxytocinDrug

    Also called Syntocinon

    For Phase I, subjects will be randomized to receive either 24IU (6 sprays) of active oxytocin or 6 sprays of placebo (3 sprays per nostril)

    For Phase II, subjects will be randomized to receive either 8 IU or 40 IU of oxytocin.

Study groups in NCT01945957
Study groupRoleWhat they receive
OT (24 IU)ExperimentalPhase I Aim 1a. (fMRI) Will determine the effect of oxytocin dose (24 IU) on neural activation and connectivity compared to placebo. Aim 1 b (eye-tracking) will occur on a separate visit from fMRI scanning and will also assess response to oxytocin in an eye-tracking task (social vs. non-social image).
Receives: Drug: Oxytocin
OT (8 IU and 40IU)ExperimentalEach phase will require a separate subject consent. Phase II Aim 2a. (fMRI) Will determine the effect of oxytocin dose (8 or 40 IU) on neural activation and connectivity. Aim 1 b (eye-tracking) will occur on a separate visit from fMRI scanning and will also assess response to oxytocin (8 or 40 IU) in an eye-tracking task (social vs. non-social image).
Receives: Drug: Oxytocin

What is being measured

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

  1. Aim 1a. fMRI Activation Analysis/Connectivity

    Activation data will be analyzed using FEAT within FSL (Oxford University, U.K.). Onset times of events will be used to model BOLD signal responses containing a regressor for each response type convolved with a double-γ function. A priority region of interest will be the VTA and NAc which will be analyzed via anatomically defined ROI's.

    Connectivity Analysis:Time series will be extracted from ROIs using FSL Featquery for each participant and averaged separately for each Treatment (OT, placebo) and Trial Type (rewarded, unrewarded) condition (seed and target regions will be functionally defined on the basis of task response). Correlation coefficients will be transformed using a Fisher r-to z transformation. Mean z-transformed values will then be computed across participants and ROI pairs, and then converted back to correlation coefficients.

    Measured: 30, 75 minutes post dose

  2. Aim 1b. Proportion of Time Attending to Social Stimuli (Eye Tracking)

    The eye tracking task involves the participant looking at a series of images in which a person's face occupies ½ the screen and a complex object occupies the other half of the screen that are presented for ~20 seconds each on a computer monitor. The participant is only told to look at the screen and sits approximately 18-24 inches in front of a computer monitor with built in cameras and lights to track eye movement. This is referred to as competitive attention task to social and nonsocial stimuli. Eye tracking will be assessed via a Tobii 1750 eye tracker or via mobile eye tracking, immediately after the fMRI scan, participants will participate in a 10 min lab-based eye tracking task in which a series of paired social and nonsocial stimuli are displayed for 10 seconds.

    Measured: pre dose and then 30, 60,120-240 minutes post dose

Secondary outcomes (5)

  1. Plasma Oxytocin (OT) levels in aim 1b. and 2b.

    We will assay plasma oxytocin levels using standard radioimmuno assays to describe potential relationships between baseline levels, salivary oxytocin and fMRI activity. Total Volume of Blood = 7ml per time point (one 7ml lavender top tube).

    Measured: pre dose and then 30, 120, 240 and 360 minutes post dose

  2. Salivary Oxytocin (OT) levels for all aims.

    We plan to collect salivary at times that coincide with the administration of the fMRI task. This data will be used to describe potential relationships between baseline levels, salivary oxytocin and fMRI activity. Collection involves inserting a cotton swab in the subjects mouth and be asked to keep it there for up to 5 minute to ensure total saturation of the swab.

    Measured: pre dose and then 30, 60, 120-240 minutes post dose for aims 1b, 2b. predose, 25min and 95 min post dose for aims 1a, 2a.

  3. SRS-Social Responsiveness Scale

    Social symptom severity will be measured with the Social Responsiveness Scale (SRS).

    Measured: at the scanner visit and eye-tracking visit

  4. Pervasive Developmental Disorders Behavior Inventory-Screening Version (PDDBI-SV)

    Social symptom severity will also be assessed with the PDDBI-SV

    Measured: at the scanner visit and eye-tracking visit

  5. ABC-lethargy/social withdrawal subscale

    Aberrant Behavior Checklist (ABC) lethargy/social withdrawal subscale

    Measured: at the scanner visit and eye-tracking visit

Timeline

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

  1. First posted19 Sep 2013 (estimated)
  2. Study startSep 2014
  3. Primary completionJan 2017
  4. Study completionJan 2017

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01945957
Sponsor's protocol ID
12-2622
Other IDs
U54HD079124-01
Status last verified
Aug 2016
First submitted
15 Feb 2013
Last updated
25 Apr 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oxytocin in people with Autism Spectrum Disorders, run by University of North Carolina, Chapel Hill 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 5 inclusion and 13 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 25 Apr 2017. 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?

Aim 1a. fMRI Activation Analysis/Connectivity (time frame: 30, 75 minutes post dose). The study lists 2 primary outcomes in all. 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 NCT01945957.

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 25 Apr 2017.

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