The Influence of Oxytocin on Socio-communicative Sensitivity
Primary Purpose
Oxytocin
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Oxytocin
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Oxytocin focused on measuring oxytocin, emotion recognition, emotion processing, social salience, face processing, Electroencephalography (EEG)
Eligibility Criteria
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
Sites / Locations
- Biomedical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oxytocin
Placebo
Arm Description
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)
Physiological water (sodium chloride (NaCl) solution) Administration via nasal spray
Outcomes
Primary Outcome Measures
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).
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)
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)
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)
Secondary Outcome Measures
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
resting state EEG
EEG recording, while presenting a fixation cross
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.
Social phobia: Social Phobia Inventory (SPIN)
A 17-item questionnaire that screens for, and measures, the severity of social anxiety disorder.
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03096249
Brief Title
The Influence of Oxytocin on Socio-communicative Sensitivity
Official Title
Monitoring the Influence of Oxytocin on Socio-communicative Sensitivity Using Fast Periodic Visual Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 21, 2016 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
July 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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:
A frequency-tagging FPVS paradigm, to measure the salience of social versus non-social stimuli.
The oddball face detection paradigm, to assess the neural sensitivity to faces embedded in a series of objects.
The oddball identity discrimination task, to examine the ability to discriminate between faces with a different identity.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxytocin
Keywords
oxytocin, emotion recognition, emotion processing, social salience, face processing, Electroencephalography (EEG)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Physiological water (sodium chloride (NaCl) solution) Administration via nasal spray
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
Syntocinon nasal spray: single dose of 24IU (3 puffs of 4IU per nostril)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo spray: single dose (3 puffs per nostril).
Primary Outcome Measure Information:
Title
social salience frequency-tagging FPVS
Description
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).
Time Frame
random: 30-70 minutes after nasal spray
Title
Oddball face detection FPVS paradigm
Description
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)
Time Frame
random: 30-70 minutes after nasal spray
Title
Oddball identity discrimination FPVS paradigm
Description
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)
Time Frame
random: 30-70 minutes after nasal spray
Title
Oddball expression generalization FPVS paradigm
Description
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)
Time Frame
random: 30-70 minutes after nasal spray
Secondary Outcome Measure Information:
Title
Emotion recognition: accuracy on the Palermo Matching task (65 items)
Description
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
Time Frame
80 minutes after nasal spray (after all EEG measures)
Title
resting state EEG
Description
EEG recording, while presenting a fixation cross
Time Frame
45-50 minutes after nasal spray (after two FPVS paradigms)
Title
Social responsiveness: Social Responsiveness Scale (SRS)
Description
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.
Time Frame
Baseline
Title
Social phobia: Social Phobia Inventory (SPIN)
Description
A 17-item questionnaire that screens for, and measures, the severity of social anxiety disorder.
Time Frame
Baseline
Title
Attachment: State Adult Attachment Measure (SAAM)
Description
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).
Time Frame
Baseline
Title
Mood: Positive And Negative Affect Schedule (PANAS)
Description
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).
Time Frame
90 minutes after nasal spray
Other Pre-specified Outcome Measures:
Title
side-effect questionnaire
Time Frame
90 minutes after nasal spray
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaat Alaerts, Professor
Organizational Affiliation
KU Leuven (Catholic University Leuven)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Biomedical Sciences
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Influence of Oxytocin on Socio-communicative Sensitivity
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