The Influence of Oxytocin on Socio-communicative Sensitivity

Monitoring the Influence of Oxytocin on Socio-communicative Sensitivity Using Fast Periodic Visual Stimulation

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).

Study Overview

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

Detailed Description

The present study is a double-blind, randomized, placebo-controlled, crossover clinical trial, in which (approximately 30) neurotypical male adults (18 to 30 years old) will participate. All participants will perform two sessions (OT and placebo), separated by two weeks. For the first session, the participants are randomly assigned to the placebo or the OT condition. Syntocinon nasal spray will be used for intranasal administration.

In each session, we will measure the neural salience/sensitivity for socio-emotional information, by recording EEG during FPVS. Participants simply have to press a button when the fixation cross turns red, while watching rapidly alternating visual stimuli. Starting 20 minutes after substance intake, four FPVS paradigms are administered in randomized order:

1. A frequency-tagging FPVS paradigm, to measure the salience of social versus non-social stimuli.
2. The oddball face detection paradigm, to assess the neural sensitivity to faces embedded in a series of objects.
3. The oddball identity discrimination task, to examine the ability to discriminate between faces with a different identity.
4. The oddball expression generalization task, to investigate the sensitivity for facial emotional expressions embedded within neutral faces with varying identities.

After two FPVS paradigms, a four minutes resting state EEG measure will be performed. At the end of the session, emotion recognition will be measures with the Palermo matching task (65 items).

The primary aim is to investigate whether the performance on each of these paradigms/tasks differs between the OT and the placebo condition. Furthermore, we want to explore whether the effect of OT is influenced by the participant's attachment style, social responsiveness, social phobia, or mood, which will be assessed via self-reported questionnaires.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Biomedical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxytocin; 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; Syntocinon nasal spray: single dose of 24IU (3 puffs of 4IU per nostril)
Placebo Comparator: Placebo; Physiological water (sodium chloride (NaCl) solution) Administration via nasal spray	Other: Placebo; Placebo spray: single dose (3 puffs per nostril).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotion recognition: accuracy on the Palermo Matching task (65 items)	Three faces are shown on the screen. Two of them display the same emotion and the participant has to indicate which face shows a different emotion	80 minutes after nasal spray (after all EEG measures)
resting state EEG	EEG recording, while presenting a fixation cross	45-50 minutes after nasal spray (after two FPVS paradigms)
Social responsiveness: Social Responsiveness Scale (SRS)	Self-report version of the SRS. In addition to a Total score reflecting severity of social deficits in the autism spectrum, the SRS generates scores for five Treatment subscales: Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests and Repetitive Behavior.	Baseline
Social phobia: Social Phobia Inventory (SPIN)	A 17-item questionnaire that screens for, and measures, the severity of social anxiety disorder.	Baseline
Attachment: State Adult Attachment Measure (SAAM)	The SAAM measures 3 different aspects of adult attachment: Security, Anxiety, Avoidance. There are 21 Likert-style questions with a score between 1 and 7 (7 for each of the three subscales).	Baseline
Mood: Positive And Negative Affect Schedule (PANAS)	The Positive and Negative Affect Schedule (PANAS) comprises two mood scales, one that measures positive affect and the other which measures negative affect. It consists of 20 items (10 for each subscale).	90 minutes after nasal spray

Other Outcome Measures

Outcome Measure	Time Frame
side-effect questionnaire	90 minutes after nasal spray

Collaborators and Investigators

• Sponsor: KU Leuven
• Investigators: Principal Investigator: Kaat Alaerts, Professor, KU Leuven (Catholic University Leuven)

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2016
• Primary Completion (Actual): May 30, 2017
• Study Completion (Actual): July 30, 2017

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 30, 2017

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: oxytocin; emotion processing; Electroencephalography (EEG); emotion recognition; social salience; face processing
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: SingleOT_EEG_S56327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No