A Phase 2 interventional study of Oxytocin and Placebo in The Impact of Oxytocin on Social Cognition, sponsored by RWTH Aachen University. Status unknown at 1 site in Germany. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-30.
Sponsored by RWTH Aachen University · Phase 2, Interventional, and Basic science
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.
RWTH Aachen University is the lead sponsor of 228 studies on the registry; 19 are open to participants now.
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fMRI measurement and blood examinations following 26 IU Oxytocin (Syntocinon) on day 1 and following placebo on day 14
Drug: Oxytocin · Drug: Placebo
fMRI measurement and blood examinations following placebo on day 1 and following 26 IU Oxytocin (Syntocinon) on day 14
Drug: Oxytocin · Drug: Placebo
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.
Time frame: (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.
Time frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Serum levels of Oxytocin
Time frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Serum levels of Prolaktin
Time frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
Serum levels of Cortisol
Time frame: (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.
Time frame: (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.
Time frame: (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).
Time frame: (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).
Time frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])
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RWTH Aachen University