A Phase 1 interventional study of Oxytocin in Autism Spectrum Disorders, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-04-25.
Sponsored by University of North Carolina, Chapel Hill · Phase 1, Interventional, and Other
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.
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 33 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
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Exclusion Criteria:
Phase 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).
Drug: Oxytocin
Each 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).
Drug: Oxytocin
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.
Also known as: Syntocinon
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.
Time frame: 30, 75 minutes post dose
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.
Time frame: pre dose and then 30, 60,120-240 minutes post dose
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).
Time frame: pre dose and then 30, 120, 240 and 360 minutes post dose
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.
Time frame: 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.
SRS-Social Responsiveness Scale
Social symptom severity will be measured with the Social Responsiveness Scale (SRS).
Time frame: at the scanner visit and eye-tracking visit
Pervasive Developmental Disorders Behavior Inventory-Screening Version (PDDBI-SV)
Social symptom severity will also be assessed with the PDDBI-SV
Time frame: at the scanner visit and eye-tracking visit
ABC-lethargy/social withdrawal subscale
Aberrant Behavior Checklist (ABC) lethargy/social withdrawal subscale
Time frame: at the scanner visit and eye-tracking visit
Caregivers will complete the Hollingshead Two-Factor Index of Social Position (only if not done previously in trial), the Repetitive Behavior Scale (revised), and the other subscales of the Aberrant Behavior Checklist
to further characterize participants with regard to socioeconomic status, lower-order and higher-order repetitive behaviors, and other problem behaviors, respectively
Time frame: at the scanner visit and eye-tracking visit
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill