NCT03255148

Brief Summary

In this study, the investigators will explore the influence of oxytocin administration on several neurophysiological responses (EEG, skin conductance and heart rate) during rest.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2017

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

July 24, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2018

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

10 months

First QC Date

August 11, 2017

Last Update Submit

July 31, 2019

Conditions

Oxytocin

Keywords

resting stateEEGskin conductanceheart rateoxytocin

Outcome Measures

Primary Outcomes (1)

  • Change in heart rate variability after oxytocin administration

    The influence of oxytocin administration on heart rate variability

    Assessment over 5 minutes, before and after oxytocin or placebo administration

Secondary Outcomes (1)

  • Change in skin conductance level after oxytocin administration

    Assessment over 5 minutes, before and after oxytocin or placebo administration

Study Arms (2)

Oxytocin

EXPERIMENTAL

Syntocinon nasal spray (40 IU/ml; oxytocin, product code RVG 03716); single intranasal dose of 24 international units (IU; 3 puffs of 4 IU per nostril)

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

saline natriumchloride solution nasal spray; single intranasal dose (3 puffs per nostril)

Drug: Placebo

Interventions

OxytocinDRUG

Syntocinon nasal spray

Also known as: syntocinon
Oxytocin
PlaceboDRUG

Placebo nasal spray

Placebo

Eligibility Criteria

Age18 Years - 38 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • right-handed
  • male
  • age between 18 and 35
  • Normal or adjusted-to-normal vision (with lenses only)
  • Dutch as mother tongue

You may not qualify if:

  • not right-handed
  • female
  • age below 18 or above 35
  • Need to wear glasses
  • Dutch not as mother tongue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Kaat Alaerts, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Kaat Alaerts

Study Record Dates

First Submitted

August 11, 2017

First Posted

August 21, 2017

Study Start

July 24, 2017

Primary Completion

May 18, 2018

Study Completion

May 18, 2018

Last Updated

August 1, 2019

Record last verified: 2019-07

Locations

BE(1)