Temporal Dynamics and Pharmacokinetics of Intranasally Administered Oxytocin

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: Oxytocin

• Registration Number: NCT03011970
• Lead Sponsor: University Hospital, Bonn

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-12
• Study Completion: 2016-02
• Study First Submitted: 2016-12-12
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-03
• Last Update Submitted: 2017-01-03
• Study First Posted: 2017-01-06
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 116

Inclusion Criteria

• Healthy male volunteers
• Right-handed

Exclusion Criteria

• Current or past psychiatric disease
• Current or past physical illness
• Psychoactive medication
• Tobacco smokers
• MRI contraindication (e.g. metal in body, claustrophobia)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo nasal spray.
Oxytocin; 24IU, 15min	Oxytocin	Intranasal administration, 24 international units (IU) oxytocin. Imaging starting 15min after nasal spray administration.
Oxytocin; 48IU, 45min	Oxytocin	Intranasal administration, 48 IU oxytocin. Imaging starting 45min after nasal spray administration
Oxytocin; 24IU, 75min	Oxytocin	Intranasal administration, 24 IU oxytocin. Imaging starting 75min after nasal spray administration.
Oxytocin; 24IU, 45min	Oxytocin	Intranasal administration, 24 IU oxytocin. Imaging starting 45min after nasal spray administration.
Oxytocin; 12IU, 45min	Oxytocin	Intranasal administration, 12 IU oxytocin. Imaging starting 45min after nasal spray administration

Primary Outcome Measures

Name	Time	Method
Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in the amygdala	45min after nasal spray administration	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).

Secondary Outcome Measures

Name	Time	Method
Ratings of emotional faces	45min after nasal spray administration	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.
Questionnaire measurement of mood (PANAS)	10 min before and 105 min after nasal spray administration	Positive and negative affect is assessed via self-rating questionnaire 'The Positive and Negative Affect Schedule' using a categorical 5 point scale.
Questionnaire measurement of anxiety (STAI).	10 min before and 105 min after nasal spray administration	State anxiety is assessed via self-rating questionnaire 'and State Trait Anxiety Inventory' using a categorical 4 point scale.
Saliva oxytocin concentrations	immediately before the nasal spray administration and (on average) 15,40,80 and 105 min after administration
Plasma oxytocin concentrations	immediately before the nasal spray administration and immediately after the fMRI experiment
Modulatory effects of autistic like traits on neural and behavioral outcome measures	screening session, ~7days prior to imaging session	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.

Trial Locations

Locations (1)

Department of Psychiatry, University of Bonn; 🇩🇪 Bonn, North Rhine-Westphalia, Germany