Effects of Oxytocin on Emotion Recognition and Response Inhibition

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.

Study Overview

• Status: Unknown
• Conditions: The Impact of Oxytocin on Social Cognition
• Intervention / Treatment: Drug: Placebo; Drug: Oxytocin

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lisa Deuse; Phone Number: 02418085692; Email: ldeuse@ukaachen.de
• Study Contact Backup: Name: Sarah E Groppe; Phone Number: 02418037151; Email: sgroppe@ukaachen.de

Study Locations

• Germany
  • Aachen, Germany
    • Recruiting
    • University Hospital RWTH Aachen
    • Contact: Lisa Deuse; Phone Number: 02418085692; Email: ldeuse@ukaachen.de
    • Principal Investigator: Gerhard Gründer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cross over Oxytocin and Placebo; fMRI measurement and blood examinations following 26 IU Oxytocin (Syntocinon) on day 1 and following placebo on day 14	Drug: Placebo; Drug: Oxytocin
Experimental: Cross over Placebo and Oxytocin; fMRI measurement and blood examinations following placebo on day 1 and following 26 IU Oxytocin (Syntocinon) on day 14	Drug: Placebo; Drug: Oxytocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BOLD response during emotion recognition in contrast with a corresponding control condition.	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.	(Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
BOLD response during response inhibition (Emotional Go/ Nogo) in contrast with a corresponding control condition.	Brain activation during NoGo trials will be compared to brain activation during Go trials from the same emotional condition.	(Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum levels of Oxytocin		(Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Serum levels of Prolaktin		(Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Serum levels of Cortisol		(Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Total length of fixations on areas of interest (AOIs) assessed via eye-tracking	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.	(Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Number of fixations on areas of interest (AOIs) assessed via eye-tracking	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.	(Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
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])
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])

Collaborators and Investigators

• Sponsor: RWTH Aachen University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: January 20, 2015
• First Submitted That Met QC Criteria: January 26, 2015
• First Posted (Estimate): January 30, 2015

Study Record Updates

• Last Update Posted (Estimate): January 30, 2015
• Last Update Submitted That Met QC Criteria: January 26, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: EK163/13