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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Oxytocin; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

• with MRI Contraindications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; intranasally administrated
Placebo Comparator: Placebo; Placebo contains all ingredients except for the peptide in three puffs of 1.33 IU per 2.24mg nostril.	Drug: Placebo; intranasally administrated; Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	70~85 minutes after drug administration
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.	60~75 minutes after drug administration
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.	35~60 minutes after drug administration
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.	60~85 minutes after drug administration

Collaborators and Investigators

• Sponsor: Beijing Normal University
• Investigators: Principal Investigator: Yina Ma, PhD, School of Brain and Cognitive Sciences, Beijing Nornal University

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2016
• Primary Completion (Actual): April 25, 2017
• Study Completion (Actual): September 12, 2017

Study Registration Dates

• First Submitted: February 4, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: intranasal oxytocin; functional brain network; multiple tasks; resting state
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: IN-OT functional network

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No