A Phase 1 interventional study of Oxytocin and Placebo in Healthy, sponsored by University Hospital, Bonn. Completed at 1 site in Germany. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-06.
Sponsored by University Hospital, Bonn · Phase 1, Interventional, and Basic science
The purpose of this study is to determine whether effects of intranasal oxytocin on amygdala response vary as a function of treatment dose and dose-test latency.
The objective of the present study is to determine whether intranasal oxytocin (IN-OXT) effects on blood oxygenation level-dependent functional magnetic resonance imaging (BOLD fMRI) in the amygdala vary as a function of dose and latency. In particular, the investigators plan to compare effects of three different IN-OXT doses (12, 24, and 48 international units, IU) and three different dose-test latencies of IN-OXT administration (task starting at 15, 45 and 75min after administration) on established neural and behavioural correlates of emotion processing. As effects of OXT are particularly promising in autism, the investigators further want to investigate how autistic-like traits influence the OXT effects in exploratory post-hoc analyses
University Hospital, Bonn is the lead sponsor of 154 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
Intranasal administration, 24 international units (IU) oxytocin. Imaging starting 15min after nasal spray administration.
Drug: Oxytocin
Intranasal administration, 24 IU oxytocin. Imaging starting 45min after nasal spray administration.
Drug: Oxytocin
Intranasal administration, 24 IU oxytocin. Imaging starting 75min after nasal spray administration.
Drug: Oxytocin
Intranasal administration, 12 IU oxytocin. Imaging starting 45min after nasal spray administration
Drug: Oxytocin
Intranasal administration, 48 IU oxytocin. Imaging starting 45min after nasal spray administration
Drug: Oxytocin
Placebo nasal spray.
Drug: Placebo
Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in the amygdala
Magnetic resonance imaging (MRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli of varying intensity. The investigators specifically plan to investigate amygdala response to fearful faces, as this subcortical region has repeatedly been reported to show activation changes after OXT treatment. Dose-test latency varies between the different treatment arms (i.e. imaging starts 15min \[arm 1\], 45min \[arm 2,4 and 5\] or 75min \[arm 3\] after nasal spray administration).
Time frame: 45min after nasal spray administration
Ratings of emotional faces
During each trial, subjects are asked to use a button response grip to indicate whether they perceived the depicted face as neutral, fearful or happy. Depending on the treatment arm, ratings are recorded 15min (arm 1), 45min (arm 2,4 and 5) or 75min (arm 3) after nasal spray administration.
Time frame: 45min after nasal spray administration
Questionnaire measurement of mood (PANAS)
Positive and negative affect is assessed via self-rating questionnaire 'The Positive and Negative Affect Schedule' using a categorical 5 point scale.
Time frame: 10 min before and 105 min after nasal spray administration
Questionnaire measurement of anxiety (STAI).
State anxiety is assessed via self-rating questionnaire 'and State Trait Anxiety Inventory' using a categorical 4 point scale.
Time frame: 10 min before and 105 min after nasal spray administration
Saliva oxytocin concentrations
Time frame: immediately before the nasal spray administration and (on average) 15,40,80 and 105 min after administration
Plasma oxytocin concentrations
Time frame: immediately before the nasal spray administration and immediately after the fMRI experiment
Modulatory effects of autistic like traits on neural and behavioral outcome measures
Autistic like traits are assessed via Autism Spectrum quotient in a screening session, preceding the testing sessions. The investigators expect pronounced OXT effects in subjects with high autistic-like traits.
Time frame: screening session, ~7days prior to imaging session
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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University Hospital, Bonn