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CompletedNCT03428906Updated Feb 12, 2018

Effects of Intranasal Oxytocin on Functional Brain Network in Resting-state and Tasks

An interventional study of Oxytocin and Placebo in Healthy, sponsored by Beijing Normal University. Completed at 1 site in China. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-12.

Sponsored by Beijing Normal University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Male
01

Study summary

To investigate whether and how intranasal oxytocin of 8IU treatment will alter the topology of functional brain network in resting-state and multiple tasks in healthy males.

Read the detailed description

In a randomized, double-blind, cross-over, placebo controlled design, healthy male volunteers receive intranasal oxytocin or placebo prior to functional magnetic resonance imaging.Subjects will then go through a decision making task, a emotion judgement task and an eight-minute resting-state scan in MRI scanner to investigate whether and how intranasal oxytocin alter the topology of functional brain network in resting-state and multiple tasks in healthy males. State anxiety and mood are measured before and after experiment as covariates to be controlled.

02

Conditions studied

  • Healthy

Keywords

  • intranasal oxytocin
  • functional brain network
  • multiple tasks
  • resting state
03

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy subjects without past or current psychiatric or neurological disorders

Exclusion criteria

Exclusion Criteria:

  • with MRI Contraindications
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Oxytocin

    Oxytocin (OXT), a neuropeptide produced in the hypothalamus, is a key modulator of complex socioaffective responses including affiliation, social approach and attachment, stress and anxiety. Subjects receiving an intranasal spray of OXT (8 IU or 13.44 mg; Syntocinon-spray; Novartis, Switzerland) .

    Drug: Oxytocin

  • Placebo comparator
    Placebo

    Placebo contains all ingredients except for the peptide in three puffs of 1.33 IU per 2.24mg nostril.

    Drug: Placebo

Interventions

  • DrugOxytocin

    intranasally administrated

  • DrugPlacebo

    intranasally administrated

    Also known as: Saline

05

What researchers measure

Primary outcomes

  1. Functional network organization alterations in brain under resting state fMRI after drug administration

    Using seed-based and network level functional connectivity analysis, as well as graph theory analysis , functional network organization in brain under eight minutes resting state will be detected and compared between oxytocin and placebo group.

    Time frame: 70~85 minutes after drug administration

  2. Behavior,brain activities and representation patterns in the emotional judgement task after drug administration

    Friend or Foe Task is used to measure the verbal versus nonverbal emotional judgement of subjects. Both the response of subjects and the brain activity are recorded in the task. How oxytocin influences the relationship between subjects' behavior and representation pattern of emotional judgement will be investigated through RSA(representation similarity analysis) of brain pattern.

    Time frame: 60~75 minutes after drug administration

  3. Behavior, dynamics brain activities and networks in the model-based decision making task after drug administration

    Two-Stage Decision Making Task is used to measure the model-based and model-free decision making process of subjects. The degree of model-based will be calculated by Computational modelling of Subjects' decision making process, and entering as modulation parameter in the OT effect on dynamic brain seed-based and network-based connectivity pattern.

    Time frame: 35~60 minutes after drug administration

  4. Relationship of functional network organization in brain across resting state and task-based fMRI after drug administration

    The functional brain activity in resting state, emotional judgement and decision making task will be compared. Both the functional segregation and integration will be measured using graph theory and network connectivity analysis to discover the OT effect on brain network organization across multiple cognitive states.

    Time frame: 60~85 minutes after drug administration

06

Study locations

1 site
  • School of Brain and Cognitive Sciences, Beijing Nornal University
    Beijing, Beijing 100875, China
07

Registry details

Key details

Study ID
NCT03428906
Lead sponsor
Beijing Normal University
Responsible party
ma, yina (Principal Investigator, Beijing Normal University) — Principal investigator
First posted
Feb 12, 2018
Start date
May 24, 2016
Primary completion
Apr 25, 2017
Completion
Sep 12, 2017
Last update
Feb 12, 2018

Study contacts

Yina Ma, PhD
principal investigator · School of Brain and Cognitive Sciences, Beijing Nornal University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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