Influence of Oxytocin on Resting State Neurophysiological Measures

Oxytocin Clinical Trial

Official title:

Influence of Oxytocin on Resting State Neurophysiological Measures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03255148
• Other study ID #: SingleOT_REST_S56327
• Status: Completed
• Phase: Phase 1
• Start date: July 24, 2017
• Est. completion date: May 18, 2018

Study information

• Verified date: July 2019
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 18, 2018
• Est. primary completion date: May 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Oxytocin

Intervention

Drug:
• Oxytocin
Syntocinon nasal spray
• Placebo
Placebo nasal spray

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heart rate variability after oxytocin administration	The influence of oxytocin administration on heart rate variability	Assessment over 5 minutes, before and after oxytocin or placebo administration
Secondary	Change in skin conductance level after oxytocin administration	The influence of oxytocin administration on skin conductance level	Assessment over 5 minutes, before and after oxytocin or placebo administration