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Temporal Dynamics and Pharmacokinetics of Intranasally Administered Oxytocin

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03011970
Enrollment
116
Registered
2017-01-06
Start date
2014-09-30
Completion date
2016-02-29
Last updated
2017-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

Interventions

DRUGOxytocin
DRUGPlacebo

Sponsors

University Hospital, Bonn
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in the amygdala45min after nasal spray administrationMagnetic 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

MeasureTime frameDescription
Questionnaire measurement of mood (PANAS)10 min before and 105 min after nasal spray administrationPositive 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 administrationState anxiety is assessed via self-rating questionnaire 'and State Trait Anxiety Inventory' using a categorical 4 point scale.
Ratings of emotional faces45min after nasal spray administrationDuring 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.
Plasma oxytocin concentrationsimmediately before the nasal spray administration and immediately after the fMRI experiment
Modulatory effects of autistic like traits on neural and behavioral outcome measuresscreening session, ~7days prior to imaging sessionAutistic 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.
Saliva oxytocin concentrationsimmediately before the nasal spray administration and (on average) 15,40,80 and 105 min after administration

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026