The Influence of Oxytocin on Socio-communicative Sensitivity

Oxytocin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03096249
• Other study ID #: SingleOT_EEG_S56327
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 21, 2016
• Est. completion date: July 30, 2017

Study information

• Verified date: July 2022
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Oxytocin

Intervention

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

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

Locations

Country	Name	City	State
Belgium	Biomedical Sciences	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	side-effect questionnaire		90 minutes after nasal spray
Primary	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
Primary	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
Primary	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
Primary	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	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)
Secondary	resting state EEG	EEG recording, while presenting a fixation cross	45-50 minutes after nasal spray (after two FPVS paradigms)
Secondary	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
Secondary	Social phobia: Social Phobia Inventory (SPIN)	A 17-item questionnaire that screens for, and measures, the severity of social anxiety disorder.	Baseline
Secondary	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
Secondary	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