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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03096249
Other study ID # SingleOT_EEG_S56327
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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