Effects of Oxytocin on Emotion Recognition and Response Inhibition

Phase 2

• Conditions: The Impact of Oxytocin on Social Cognition
• Interventions: Drug: Oxytocin; Drug: Placebo

• Registration Number: NCT02350946
• Lead Sponsor: RWTH Aachen University

Brief Summary

The purpose of this study is to shed light on the basic neurobiological mechanisms which underlie social information processing in healthy men. More specifically, we intend to examine whether a person's social competence level is related to the patterns of neural activity and his visual search strategies during evaluation of social scenes. Furthermore, it will be assessed whether an oxytocin-driven increase in activity in brain areas relevant to the task will facilitate social information processing and thus enhance task performance. Additionally it will be examined whether oxytocin can facilitate response inhibition in an emotional context.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-01
• Study Start: 2015-01
• Study First Submitted: 2015-01-20
• Study First Submitted QC: 2015-01-26
• Last Update Submitted: 2015-01-26
• Study First Posted: 2015-01-30
• Last Update Posted: 2015-01-30
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• MRI- eligibility
• Subject's ability to fully grasp the type, scope and individual consequences of the study
• Willingness to participate in and comply with the study procedures as indicated by signing the dated informed consent form

Exclusion Criteria

• Left-handedness
• Smoking
• Regular intake of medication
• Hypersensitivity towards oxytocin or a chemically similar substance
• Current or previous neurological or psychiatric disorder
• Nose surgery or chronic sinus infection
• Any somatic disorder that may interfere with the experimental procedures, affect the outcome measures or pose a risk for the participant during performance of the experiment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cross over Oxytocin and Placebo	Placebo	fMRI measurement and blood examinations following 26 IU Oxytocin (Syntocinon) on day 1 and following placebo on day 14
Cross over Placebo and Oxytocin	Placebo	fMRI measurement and blood examinations following placebo on day 1 and following 26 IU Oxytocin (Syntocinon) on day 14
Cross over Oxytocin and Placebo	Oxytocin	fMRI measurement and blood examinations following 26 IU Oxytocin (Syntocinon) on day 1 and following placebo on day 14
Cross over Placebo and Oxytocin	Oxytocin	fMRI measurement and blood examinations following placebo on day 1 and following 26 IU Oxytocin (Syntocinon) on day 14

Primary Outcome Measures

Name	Time	Method
BOLD response during emotion recognition in contrast with a corresponding control condition.	(Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])	In the Social Detection Task, subjects' brain activity when viewing social scenes will be compared to corresponding control scenes in which no people are shown.; In the GoNoGo Task several emotional conditions will be compared to a neutral control condition.
BOLD response during response inhibition (Emotional Go/ Nogo) in contrast with a corresponding control condition.	(Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])	Brain activation during NoGo trials will be compared to brain activation during Go trials from the same emotional condition.

Secondary Outcome Measures

Name	Time	Method
Total length of fixations on areas of interest (AOIs) assessed via eye-tracking	(Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])	In the SoDeTa stimulus set, faces, arms and hands were defined as 1st order AOIs and remaining parts of the body as 2nd order AOIs.; In the GoNoGo task, for each stimulus, the eye region of the face was chosen as AOI.
Percentage of correct responses in an emotion recognition paradigm (Social Detection Task) and a response inhibition task (Emotional Go/Nogo).	(Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Serum levels of Oxytocin	(Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Serum levels of Cortisol	(Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Response time in an emotion recognition paradigm (Social Detection Task) and a response inhibition task (Emotional Go/Nogo).	(Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Serum levels of Prolaktin	(Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Number of fixations on areas of interest (AOIs) assessed via eye-tracking	(Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])	In the SoDeTa stimulus set, faces, arms and hands were defined as 1st order AOIs and remaining parts of the body as 2nd order AOIs.; In the GoNoGo task, for each stimulus, the eye region of the face was chosen as AOI.

Trial Locations

Locations (1)

University Hospital RWTH Aachen; 🇩🇪 Aachen, Germany