NCT03096249

Brief Summary

Oxytocin (OT) is a neuropeptide that acts as a neurotransmitter and neuromodulator in the brain. Previous studies have shown that intranasal administration of OT improves social cognition and behavior (e.g. emotion recognition). In the current study, we want to gain more insight into the underlying mechanisms by which OT influences emotion recognition. More specifically, we will investigate whether intranasal administration of OT enhances the salience of social (compared to non-social) information and whether it increases the neural sensitivity for subtle socio-emotional cues, by recording scalp electroencephalography (EEG) during Fast Periodic Visual Stimulation (FPVS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2017

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

March 7, 2017

Last Update Submit

July 19, 2022

Conditions

Oxytocin

Keywords

oxytocinemotion recognitionemotion processingsocial salienceface processingElectroencephalography (EEG)

Outcome Measures

Primary Outcomes (4)

  • social salience frequency-tagging FPVS

    EEG recording during simultaneous (superimposed) presentation of social stimuli (faces) and non-social stimuli (objects or houses), at a frequency of 6 and 7.5Hz, respectively (counterbalanced).

    random: 30-70 minutes after nasal spray

  • Oddball face detection FPVS paradigm

    EEG recording during presentation of objects (at 6 Hz) and faces (inserted as an "oddball" every fifth image, thus at a frequency of 1.2 Hz)

    random: 30-70 minutes after nasal spray

  • Oddball identity discrimination FPVS paradigm

    EEG recording during presentation of neutral faces of the same person (same identity, presented at 6 Hz) and the face of another person (inserted as an "oddball" every fifth image, thus at a frequency of 1.2 Hz)

    random: 30-70 minutes after nasal spray

  • Oddball expression generalization FPVS paradigm

    EEG recording during presentation of neutral faces with different identities (at 6 Hz) and faces with an emotional expression (fear, anger, happy; inserted as an "oddball" every fifth image, thus at a frequency of 1.2 Hz)

    random: 30-70 minutes after nasal spray

Secondary Outcomes (6)

  • Emotion recognition: accuracy on the Palermo Matching task (65 items)

    80 minutes after nasal spray (after all EEG measures)

  • resting state EEG

    45-50 minutes after nasal spray (after two FPVS paradigms)

  • Social responsiveness: Social Responsiveness Scale (SRS)

    Baseline

  • Social phobia: Social Phobia Inventory (SPIN)

    Baseline

  • Attachment: State Adult Attachment Measure (SAAM)

    Baseline

  • +1 more secondary outcomes

Other Outcomes (1)

  • side-effect questionnaire

    90 minutes after nasal spray

Study Arms (2)

Oxytocin

EXPERIMENTAL

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

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Physiological water (sodium chloride (NaCl) solution) Administration via nasal spray

Other: Placebo

Interventions

OxytocinDRUG

Syntocinon nasal spray: single dose of 24IU (3 puffs of 4IU per nostril)

Oxytocin
PlaceboOTHER

Placebo spray: single dose (3 puffs per nostril).

Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18 and 30 years
  • male
  • right-handed
  • typically developing
  • Normal or adjusted-to-normal vision (with glasses or lenses)

You may not qualify if:

  • psychiatric disorder
  • neurological disorder (e.g. epilepsy, migraine)
  • color blindness
  • psychoactive medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomedical Sciences

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, Professor

    KU Leuven (Catholic University Leuven)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 7, 2017

First Posted

March 30, 2017

Study Start

November 21, 2016

Primary Completion

May 30, 2017

Study Completion

July 30, 2017

Last Updated

July 22, 2022

Record last verified: 2022-07

Locations

BE(1)