NCT04443647

Brief Summary

In this study, a randomized, placebo-controlled between-subject design is adopted to investigate the effect of a single-dose of intranasally administered OT on approach-avoidance related motivational tendencies during the processing of a series of social and non-social, positively and negatively valenced stimuli. To obtain a behavioral measure of approach-avoidance tendencies, participants will be able to control the viewing time of the presented stimuli, by pressing 'up' or 'down' on a keyboard. During stimulus presentation neurophysiological recordings will be performed to obtain a neural measure of approach-avoidance motivational tendencies, based on electroencephalographic recordings (EEG: frontal alpha asymmetry). Also assessments of autonomic arousal, based on skin conductance recordings will be collected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

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

December 15, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

1.1 years

First QC Date

June 17, 2020

Last Update Submit

June 19, 2020

Conditions

Basic Science

Keywords

oxytocinsocialityapproach-avoidance motivational tendenciesEEG frontal assymmetryskin conductanceautonomic arousal

Outcome Measures

Primary Outcomes (3)

  • Change in EEG frontal alpha asymmetry after nasal spray administration

    The influence of oxytocin administration on EEG frontal alpha asymmetry

    Average over trials, baseline and approximately 30 minutes after nasal spray administration

  • Change in behavioral approach-avoidance (number of up or down key presses, prolonging or shortening the viewing time towards presented stimuli)

    During the presentation of a series of stimuli, participants will be able to prolong or shorten the viewing time towards the presented stimuli, by pressing an 'up' or 'down' key on a keyboard. The number of up versus down key-presses will be taken as a measure of behavioral approach-avoidance. The influence of oxytocin administration on the number of up or down key presses will be assessed.

    Average over trials, baseline and approximately 30 minutes after nasal spray administration

  • Change in skin conductance (type of electrodermal recording) after nasal spray administration

    The influence of oxytocin adminstration on skin conductance

    Average over trials, baseline and approximately 30 minutes after nasal spray 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

Oxytocin
PlaceboDRUG

Placebo nasal spray

Placebo

Eligibility Criteria

Age18 Years - 35 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:

  • female
  • age below 18 or above 35
  • neurological or psychiatric condition (e.g. epilepsy, stroke, concussion), (e.g. anxiety disorder, depression)
  • use of psychotropic medication (e.g. anxiolytics, antidepressants)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Leuven

Leuven, 3000, Belgium

Location

Related Publications (2)

  • Harari-Dahan O, Bernstein A. A general approach-avoidance hypothesis of oxytocin: accounting for social and non-social effects of oxytocin. Neurosci Biobehav Rev. 2014 Nov;47:506-19. doi: 10.1016/j.neubiorev.2014.10.007.

    PMID: 25454355BACKGROUND

  • Alaerts K, Taillieu A, Daniels N, Soriano JR, Prinsen J. Oxytocin enhances neural approach towards social and non-social stimuli of high personal relevance. Sci Rep. 2021 Dec 8;11(1):23589. doi: 10.1038/s41598-021-02914-8.

    PMID: 34880300DERIVED

MeSH Terms

Conditions

Social Behavior

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Behavior

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
not applicable
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.

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 23, 2020

Study Start

December 15, 2018

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

June 23, 2020

Record last verified: 2020-06

Locations

BE(1)