Trial · Interventional
CompletedPhase 1/2Registry dataBelgium
1 trial · 1 completed
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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).
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)
Placebo comparator
Placebo
Physiological water (sodium chloride (NaCl) solution) Administration via nasal spray
Outcomes the sponsor listed as primary.
social salience frequency-tagging FPVS
Time frame · random: 30-70 minutes after nasal spray
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
Time frame · random: 30-70 minutes after nasal spray
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
Time frame · random: 30-70 minutes after nasal spray
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
Time frame · random: 30-70 minutes after nasal spray
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)
Emotion recognition: accuracy on the Palermo Matching task (65 items)
Time frame · 80 minutes after nasal spray (after all EEG measures)
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
Time frame · 45-50 minutes after nasal spray (after two FPVS paradigms)
EEG recording, while presenting a fixation cross
Social responsiveness: Social Responsiveness Scale (SRS)
Time frame · Baseline
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)
Time frame · Baseline
A 17-item questionnaire that screens for, and measures, the severity of social anxiety disorder.
Attachment: State Adult Attachment Measure (SAAM)
Time frame · Baseline
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)
Time frame · 90 minutes after nasal spray
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).
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
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Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2024
Tomescu et al. 2024Psychophysiologycited by 6
PMID 38594888DOI 10.1111/psyp.14581PUB-38594888
Who could join, as posted.
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