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Clinical Trials/NCT02350946
NCT02350946
Unknown
Phase 2

Effects of Oxytocin on Emotion Recognition and Response Inhibition

RWTH Aachen University1 site in 1 country40 target enrollmentJanuary 2015

Overview

Phase
Phase 2
Intervention
Oxytocin
Conditions
The Impact of Oxytocin on Social Cognition
Sponsor
RWTH Aachen University
Enrollment
40
Locations
1
Primary Endpoint
BOLD response during emotion recognition in contrast with a corresponding control condition.
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
January 2017
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility 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
  • 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

Arms & Interventions

Cross over Oxytocin and Placebo

fMRI measurement and blood examinations following 26 IU Oxytocin (Syntocinon) on day 1 and following placebo on day 14

Intervention: Oxytocin

Cross over Oxytocin and Placebo

fMRI measurement and blood examinations following 26 IU Oxytocin (Syntocinon) on day 1 and following placebo on day 14

Intervention: Placebo

Cross over Placebo and Oxytocin

fMRI measurement and blood examinations following placebo on day 1 and following 26 IU Oxytocin (Syntocinon) on day 14

Intervention: Oxytocin

Cross over Placebo and Oxytocin

fMRI measurement and blood examinations following placebo on day 1 and following 26 IU Oxytocin (Syntocinon) on day 14

Intervention: Placebo

Outcomes

Primary Outcomes

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.

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 Outcomes

  • Total length of fixations on areas of interest (AOIs) assessed via eye-tracking((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]))
  • 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]))

Study Sites (1)

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