Influence of Oxytocin on Resting State Neurophysiological Measures

Phase 1

Completed

• Conditions: Oxytocin
• Interventions: Drug: Oxytocin; Drug: Placebo

• Registration Number: NCT03255148
• Lead Sponsor: KU Leuven

Brief Summary

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

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

Study Timeline

• Study Start: 2017-07-24
• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-21
• Primary Completion: 2018-05-18
• Study Completion: 2018-05-18
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-31
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocin	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)
Placebo	Placebo	saline natriumchloride solution nasal spray; single intranasal dose (3 puffs per nostril)

Primary Outcome Measures

Name	Time	Method
Change in heart rate variability after oxytocin administration	Assessment over 5 minutes, before and after oxytocin or placebo administration	The influence of oxytocin administration on heart rate variability

Secondary Outcome Measures

Name	Time	Method
Change in skin conductance level after oxytocin administration	Assessment over 5 minutes, before and after oxytocin or placebo administration	The influence of oxytocin administration on skin conductance level

Trial Locations

Locations (1)

KU Leuven; 🇧🇪 Leuven, Belgium