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

NCT ID: NCT03428906

Last Updated: 2018-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-24

Study Completion Date

2017-09-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study utilized a randomized, double-blind, PBO controlled, within-subject design, in which each participant was tested under two acute treatment conditions separated by at least 1 wk wash-out period.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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) .

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

intranasally administrated

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

intranasally administrated

Interventions

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Oxytocin

intranasally administrated

Intervention Type DRUG

Placebo

intranasally administrated

Intervention Type DRUG

Other Intervention Names

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Saline

Eligibility Criteria

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Inclusion Criteria

* healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria

* with MRI Contraindications
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Normal University

OTHER

Sponsor Role lead

Responsible Party

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ma, yina

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yina Ma, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Brain and Cognitive Sciences, Beijing Nornal University

Locations

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School of Brain and Cognitive Sciences, Beijing Nornal University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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IN-OT functional network

Identifier Type: -

Identifier Source: org_study_id

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