Clinical trial NCT03610919: Effects of Oxytocin Dose Frequency on Behavioral and Neural Responses
Official title: Effects of Oxytocin Dose Frequency on Behavioral and Neural Responses, and Modulation by Trait Autism and Genotype
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Keywords: multiple doses
oxytocin
genotype
autism trait
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 150
Sex: MALE
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Between group differences in the changes between acute and chronic administration effects of oxytocin on amygdala reactivity towards fearful faces as assessed by fMRI.
timeFrame: 45 minutes after treatment (day 1 vs day 5)
measure: Between group differences in the changes between acute and chronic administration effects of oxytocin on amygdala resting state connectivity as assessed by fMRI.
timeFrame: 45 minutes after treatment (day 1 vs day 5)
Secondary outcomes:
measure: Association between trait autism with acute and chronic treatment effects on amygdala activity in response to fearful faces
timeFrame: 45 minutes after treatment (day 1 vs day 5)
measure: Association between trait autism with acute and chronic treatment effects on amygdala resting state connectivity
timeFrame: 45 minutes after treatment (day 1 vs day 5)
measure: Interaction of acute and chronic treatment effects on amygdala activity with oxytocin receptor genotype.
timeFrame: 45 minutes after treatment (day 1 vs day 5)
measure: Interaction of acute and chronic treatment effects on amygdala connectivity with oxytocin receptor genotype.
timeFrame: 45 minutes after treatment (day 1 vs day 5)
measure: 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
timeFrame: 45 minutes after treatment (day 1 vs day 5)
measure: 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
timeFrame: 45 minutes after treatment (day 1 vs day 5)
measure: 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
timeFrame: 45 minutes after treatment (day 1 vs day 5)
Other outcomes:
Locations:
city: Chengdu
country: China
facility: school of life science and technology, University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Keith Kendrick, PhD
role: PRINCIPAL_INVESTIGATOR
References: