A Phase 1 interventional study of Oxytocin and Placebo in Oxytocin, sponsored by KU Leuven. Completed at 1 site in Belgium. Open to male participants aged 18 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-01.
Sponsored by KU Leuven · Phase 1, Interventional, and Basic science
In this study, the investigators will explore the influence of oxytocin administration on several neurophysiological responses (EEG, skin conductance and heart rate) during rest.
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
Exclusion Criteria:
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)
Drug: Oxytocin
saline natriumchloride solution nasal spray; single intranasal dose (3 puffs per nostril)
Drug: Placebo
Syntocinon nasal spray
Also known as: syntocinon
Placebo nasal spray
Change in heart rate variability after oxytocin administration
The influence of oxytocin administration on heart rate variability
Time frame: Assessment over 5 minutes, before and after oxytocin or placebo administration
Change in skin conductance level after oxytocin administration
The influence of oxytocin administration on skin conductance level
Time frame: Assessment over 5 minutes, before and after oxytocin or placebo administration
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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KU Leuven