The Impact of Oxytocin on Social Cognition Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | January 2017 |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 45 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Hospital RWTH Aachen | Aachen |
| Lead Sponsor | Collaborator |
|---|---|
| RWTH Aachen University |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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]) | No |
| Primary | 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]) | No |
| Secondary | Serum levels of Oxytocin | (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced]) | No | |
| Secondary | Serum levels of Prolaktin | (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced]) | No | |
| Secondary | Serum levels of Cortisol | (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced]) | No | |
| Secondary | 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]) | No |
| Secondary | 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]) | No |
| Secondary | 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]) | No | |
| Secondary | 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]) | No |