Influence of Oxytocin on Resting State Neurophysiological Measures

Catholic University (KU) of Leuven

Status and phase: Completed; Phase 1

Conditions: Oxytocin

Treatments: Drug: Oxytocin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03255148

SingleOT_REST_S56327

Details and patient eligibility

About

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

Full 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

Enrollment: 56 patients

Sex: Male

Ages: 18 to 38 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups, including a placebo group

Oxytocin

Experimental group

Description:

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)

Treatment:

Drug: Oxytocin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo