Influence of Oxytocin on Resting State Neurophysiological Measures

NCT ID: NCT03255148

Last Updated: 2019-08-01

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

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-24

Study Completion Date

2018-05-18

Brief Summary

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In this study, the investigators will explore the influence of oxytocin administration on several neurophysiological responses (EEG, skin conductance and heart rate) during rest.

Detailed Description

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Oxytocin is known to influence several neurophysiological measures, such as heart rate, EEG and skin conductance during specific tasks (e.g., emotion recognition, fear learning and extinction). However, not much is known about the influence of oxytocin on those measures during rest. Therefore, in this randomized, placebo controlled, double blinded study, the investigators will investigate the influence of oxytocin during a resting period of 5 minutes. Heart rate, skin conductance, respiration and EEG will be measured before and after oxytocin or placebo administration. The investigators expect that oxytocin will increase the heart rate variability and decrease the skin conductance levels. Exploratory, the investigators will conduct a cross-frequency analysis of band power and asses the relationship between distinct indexes of sympathetic / parasympathetic balance.

Please note that this study is part of a larger study in which the investigators also asses the influence of oxytocin on neurophysiological responses elicited by direct gaze

Conditions

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Oxytocin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oxytocin

Syntocinon nasal spray (40 IU/ml; oxytocin, product code RVG 03716); single intranasal dose of 24 international units (IU; 3 puffs of 4 IU per nostril)

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Syntocinon nasal spray

Placebo

saline natriumchloride solution nasal spray; single intranasal dose (3 puffs per nostril)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo nasal spray

Interventions

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Oxytocin

Syntocinon nasal spray

Intervention Type DRUG

Placebo

Placebo nasal spray

Intervention Type DRUG

Other Intervention Names

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syntocinon

Eligibility Criteria

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Inclusion Criteria

* right-handed
* male
* age between 18 and 35
* Normal or adjusted-to-normal vision (with lenses only)
* Dutch as mother tongue

Exclusion Criteria

* not right-handed
* female
* age below 18 or above 35
* Need to wear glasses
* Dutch not as mother tongue
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Research Foundation Flanders

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Kaat Alaerts

Prof. Dr. Kaat Alaerts

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kaat Alaerts, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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KU Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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SingleOT_REST_S56327

Identifier Type: -

Identifier Source: org_study_id

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