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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Oxytocin

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 Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany, 53105
      • Department of Psychiatry, University of Bonn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oxytocin; 24IU, 15min; Intranasal administration, 24 international units (IU) oxytocin. Imaging starting 15min after nasal spray administration.	Drug: Oxytocin
Active Comparator: Oxytocin; 24IU, 45min; Intranasal administration, 24 IU oxytocin. Imaging starting 45min after nasal spray administration.	Drug: Oxytocin
Active Comparator: Oxytocin; 24IU, 75min; Intranasal administration, 24 IU oxytocin. Imaging starting 75min after nasal spray administration.	Drug: Oxytocin
Active Comparator: Oxytocin; 12IU, 45min; Intranasal administration, 12 IU oxytocin. Imaging starting 45min after nasal spray administration	Drug: Oxytocin
Active Comparator: Oxytocin; 48IU, 45min; Intranasal administration, 48 IU oxytocin. Imaging starting 45min after nasal spray administration	Drug: Oxytocin
Placebo Comparator: Placebo; Placebo nasal spray.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	45min after nasal spray administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	10 min before and 105 min after nasal spray administration
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	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.	screening session, ~7days prior to imaging session

Collaborators and Investigators

• Sponsor: University Hospital, Bonn

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (Estimate): January 6, 2017

Study Record Updates

• Last Update Posted (Estimate): January 6, 2017
• Last Update Submitted That Met QC Criteria: January 3, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: OXT_KINO