Clinical trial NCT02350946: Effects of Oxytocin on Emotion Recognition and Response Inhibition
Official title: Effects of Oxytocin on Emotion Recognition and Response Inhibition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: The Impact of Oxytocin on Social Cognition
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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
* 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

Primary outcomes:
measure: BOLD response during emotion recognition in contrast with a corresponding control condition.
timeFrame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
measure: BOLD response during response inhibition (Emotional Go/ Nogo) in contrast with a corresponding control condition.
timeFrame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Secondary outcomes:
measure: Serum levels of Oxytocin
timeFrame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
measure: Serum levels of Prolaktin
timeFrame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
measure: Serum levels of Cortisol
timeFrame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
measure: Total length of fixations on areas of interest (AOIs) assessed via eye-tracking
timeFrame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
measure: Number of fixations on areas of interest (AOIs) assessed via eye-tracking
timeFrame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
measure: Percentage of correct responses in an emotion recognition paradigm (Social Detection Task) and a response inhibition task (Emotional Go/Nogo).
timeFrame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
measure: Response time in an emotion recognition paradigm (Social Detection Task) and a response inhibition task (Emotional Go/Nogo).
timeFrame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital RWTH Aachen
Study officials:
References: