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Completed

NCT Number: NCT03011970

Temporal Dynamics and Pharmacokinetics of Intranasally Administered Oxytocin

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Department of Psychiatry, University of Bonn

Bonn, North Rhine-Westphalia, 53105, Germany

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oxytocin

Drug

Placebo

Drug

Primary outcomes

  1. Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in the amygdala

    Time frame: 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 outcomes

  1. Ratings of emotional faces

    Time frame: 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.

  2. Questionnaire measurement of mood (PANAS)

    Time frame: 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.

  3. Questionnaire measurement of anxiety (STAI).

    Time frame: 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.

  4. Saliva oxytocin concentrations

    Time frame: immediately before the nasal spray administration and (on average) 15,40,80 and 105 min after administration

  5. Plasma oxytocin concentrations

    Time frame: immediately before the nasal spray administration and immediately after the fMRI experiment

  6. Modulatory effects of autistic like traits on neural and behavioral outcome measures

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jan 6, 2017
Registry last updated
Jan 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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