NCT03011970

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

December 12, 2016

Last Update Submit

January 3, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Ratings of emotional faces

    45min after nasal spray administration

  • Questionnaire measurement of mood (PANAS)

    10 min before and 105 min after nasal spray administration

  • Questionnaire measurement of anxiety (STAI).

    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

  • +1 more secondary outcomes

Study Arms (6)

Oxytocin; 24IU, 15min

ACTIVE COMPARATOR

Intranasal administration, 24 international units (IU) oxytocin. Imaging starting 15min after nasal spray administration.

Drug: Oxytocin

Oxytocin; 24IU, 45min

ACTIVE COMPARATOR

Intranasal administration, 24 IU oxytocin. Imaging starting 45min after nasal spray administration.

Drug: Oxytocin

Oxytocin; 24IU, 75min

ACTIVE COMPARATOR

Intranasal administration, 24 IU oxytocin. Imaging starting 75min after nasal spray administration.

Drug: Oxytocin

Oxytocin; 12IU, 45min

ACTIVE COMPARATOR

Intranasal administration, 12 IU oxytocin. Imaging starting 45min after nasal spray administration

Drug: Oxytocin

Oxytocin; 48IU, 45min

ACTIVE COMPARATOR

Intranasal administration, 48 IU oxytocin. Imaging starting 45min after nasal spray administration

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Placebo nasal spray.

Drug: Placebo

Interventions

OxytocinDRUG
Oxytocin; 12IU, 45minOxytocin; 24IU, 15minOxytocin; 24IU, 45minOxytocin; 24IU, 75minOxytocin; 48IU, 45min
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers
  • Right-handed

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, University of Bonn

Bonn, North Rhine-Westphalia, 53105, Germany

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 12, 2016

First Posted

January 6, 2017

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

DE(1)