Effects of Oxytocin Dose Frequency on Behavioral and Neural Responses

Overview

The main aim of the study is to examine effects of different dose frequencies of repeated oxytocin administration on neural and behavioral markers of oxytocin in healthy male subjects. In addition modulatory effects of autism traits and oxytocin receptor genotype (OXTR) will be explored.

Full Title of Study: “Effects of Oxytocin Dose Frequency on Behavioral and Neural Responses, and Modulation by Trait Autism and Genotype”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 1, 2018

Detailed Description

In the present study, healthy male subjects will be screened according to the study inclusion criteria. After enrollment buccal swaps will be collected for genotyping and subjects will be randomly assigned to three experimental groups that will receive treatment for 5 subsequent days: (1) placebo for five days, (2) oxytocin on days 1, 3 and 5, or (3) oxytocin for five days. Behavioral measures, task-based and resting fMRI will be assessed after the first treatment (acute effects) and the last treatment (chronic effects). The task-based fMRI will employ an implicit emotional face processing paradigm and ratings of the facial emotions will be collected after the fMRI.

Moreover, to control for potential confounding effects of relevant traits all participants will complete the following questionnaires: Interpersonal Reactivity Index (IRI),Beck depression inventory (BDI), State-Trait Anxiety Inventory (STAI). To explore potential modulatory effects of trait autism, all subjects will be administered the Autism Spectrum Quotient (ASQ) scale to assess pre-treatment autism traits.

Interventions

  • Drug: Nasal Sprays
    • Intranasal administration of 24 international units per dose.

Arms, Groups and Cohorts

  • Experimental: Oxytocin nasal spray(5 doses)
    • Oxytocin nasal spray for 5 days, 24 IU per day
  • Experimental: Oxytocin nasal spray(3 doses)
    • Oxytocin nasal spray or placebo nasal spray interleaved during the 5 days( on the 1st,3rd and 5th day),24 IU per day.
  • Placebo Comparator: Placebo nasal spray(control group)
    • Placebo nasal spray for 5 days,24 IU per day.

Clinical Trial Outcome Measures

Primary Measures

  • Between group differences in the changes between acute and chronic administration effects of oxytocin on amygdala reactivity towards fearful faces as assessed by fMRI.
    • Time Frame: 45 minutes after treatment (day 1 vs day 5)
    • Differences between the treatment groups will be determined by examining differential changes of acute treatment (day 1) vs chronic treatment (day 5) on amygdala activity towards fearful faces. Amygdala activity will be assessed using task-based BOLD fMRI analyses.
  • Between group differences in the changes between acute and chronic administration effects of oxytocin on amygdala resting state connectivity as assessed by fMRI.
    • Time Frame: 45 minutes after treatment (day 1 vs day 5)
    • Differences between the treatment groups will be determined by examining differential changes of acute treatment (day 1) vs chronic treatment (day 5) on amygdala resting state fMRI connectivity. Amygdala functional connectivity will be examined using a seed to whole brain approach.

Secondary Measures

  • Association between trait autism with acute and chronic treatment effects on amygdala activity in response to fearful faces
    • Time Frame: 45 minutes after treatment (day 1 vs day 5)
    • Associations between autism traits and amygdala response to fearful faces during acute effects (single dose, day 1) and chronic effects (over the course of 5 days) will be examined by means of correlation analyses. Pre-treatment autism trait scores will be assessed using the Autism Spectrum Quotient (ASQ)
  • Association between trait autism with acute and chronic treatment effects on amygdala resting state connectivity
    • Time Frame: 45 minutes after treatment (day 1 vs day 5)
    • Associations between autism traits and amygdala resting state connectivity during acute effects (single dose, day 1) and chronic effects (over the course of 5 days) will be examined by means of correlation analyses. Pre-treatment autism trait scores will be assessed using the Autism Spectrum Quotient (ASQ)
  • Interaction of acute and chronic treatment effects on amygdala activity with oxytocin receptor genotype.
    • Time Frame: 45 minutes after treatment (day 1 vs day 5)
    • Participants will be divided in sub-groups according to their oxytocin receptor (OXTR) genetic profile. Modulatory effects of the OXTR on acute and chronic effects will be explored by comparing effects of treatment on amygdala activity in response to fearful faces as assessed by fMRI between the genotype groups.
  • Interaction of acute and chronic treatment effects on amygdala connectivity with oxytocin receptor genotype.
    • Time Frame: 45 minutes after treatment (day 1 vs day 5)
    • Participants will be divided in sub-groups according to their oxytocin receptor (OXTR) genetic profile. Modulatory effects of the OXTR on acute and chronic effects will be explored by comparing effects of treatment on amygdala resting state connectivity as assessed by fMRI between the genotype groups.
  • Treatment effects on arousal will be assessed by subjects rating their arousal on a 9-point Likert scale in response to the face pictures presented again after their fMRI scans on day 1 and day 5
    • Time Frame: 45 minutes after treatment (day 1 vs day 5)
    • After assessment of the implicit fMRI emotional face paradigm participants will rate the emotional arousal of the stimuli using Likert scales (9 point). Acute and chronic effects will be assessed using repeated measures ANOVAs (day 1 vs day 5) to compare differential changes between the groups.
  • Treatment effects on valence will be assessed by subjects rating their valence on a 9 point Likert scale in response to the face pictures presented again after their fMRI scans on day 1 and day 5
    • Time Frame: 45 minutes after treatment (day 1 vs day 5)
    • After assessment of the implicit fMRI emotional face paradigm participants will rate the emotional valence of the stimuli using Likert scales (9 point). Acute and chronic effects will be assessed using repeated measures ANOVAs (day 1 vs day 5) to compare differential changes between the groups.
  • Treatment effects on intensity will be assessed by subjects rating their intensity on a 9 point Likert scale in response to the face pictures presented again after their fMRI scans on day 1 and day 5
    • Time Frame: 45 minutes after treatment (day 1 vs day 5)
    • After assessment of the implicit fMRI emotional face paradigm participants will rate the emotional intensity of the stimuli using Likert scales (9 point). Acute and chronic effects will be assessed using repeated measures ANOVAs (day 1 vs day 5) to compare differential changes between the groups.

Participating in This Clinical Trial

Inclusion Criteria

  • healthy adult males

Exclusion Criteria

  • past or current psychiatric or neurological disorder head trauma substance abuse medication fMRI contraindications (e.g. metal implants)

Gender Eligibility: Male

Minimum Age: 17 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Electronic Science and Technology of China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Keith Kendrick, professor – University of Electronic Science and Technology of China
  • Overall Official(s)
    • Keith Kendrick, PhD, Principal Investigator, University of Electronic Science and Technology of China
  • Overall Contact(s)
    • Benjamin Becker, PhD, +86 2861 830 811, ben_becker@gmx.de

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