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Effects of Oxytocin on Emotion Recognition and Response Inhibition

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ClinicalTrials.gov Identifier: NCT02350946
Recruitment Status : Unknown
Verified January 2015 by RWTH Aachen University.
Recruitment status was:  Recruiting
First Posted : January 30, 2015
Last Update Posted : January 30, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
The Impact of Oxytocin on Social Cognition Drug: Oxytocin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Oxytocin on Emotion Recognition and Response Inhibition
Study Start Date : January 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

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: Oxytocin
Drug: Placebo
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: Oxytocin
Drug: Placebo



Primary Outcome Measures :
  1. BOLD response during emotion recognition in contrast with a corresponding control condition. [ Time Frame: (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.


  2. BOLD response during response inhibition (Emotional Go/ Nogo) in contrast with a corresponding control condition. [ Time Frame: (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 :
  1. Serum levels of Oxytocin [ Time Frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced]) ]
  2. Serum levels of Prolaktin [ Time Frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced]) ]
  3. Serum levels of Cortisol [ Time Frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced]) ]
  4. Total length of fixations on areas of interest (AOIs) assessed via eye-tracking [ Time Frame: (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.


  5. Number of fixations on areas of interest (AOIs) assessed via eye-tracking [ Time Frame: (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.


  6. Percentage of correct responses in an emotion recognition paradigm (Social Detection Task) and a response inhibition task (Emotional Go/Nogo). [ Time Frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced]) ]
  7. Response time in an emotion recognition paradigm (Social Detection Task) and a response inhibition task (Emotional Go/Nogo). [ Time Frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced]) ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350946


Contacts
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Contact: Lisa Deuse 02418085692 ldeuse@ukaachen.de
Contact: Sarah E Groppe 02418037151 sgroppe@ukaachen.de

Locations
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Germany
University Hospital RWTH Aachen Recruiting
Aachen, Germany
Contact: Lisa Deuse    02418085692    ldeuse@ukaachen.de   
Principal Investigator: Gerhard Gründer         
Sponsors and Collaborators
RWTH Aachen University
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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02350946    
Other Study ID Numbers: EK163/13
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: January 30, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs