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OxytocinPhase 1/2NCT03096249

The Influence of Oxytocin on Socio-communicative Sensitivity

A Phase 1/2 study testing Oxytocin in people with Oxytocin, run by KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for
Oxytocin
What is being tested?
Oxytocin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
1 siteBelgium
Study dates
21 Nov 2016to 30 Jul 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Biomedical Sciences

    Leuven, 3000

Other trials in Belgium

About this study

Official title: 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).

Read the 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.

Conditions
Oxytocin
Being tested
Oxytocin, Placebo
Keywords
oxytocin, emotion recognition, emotion processing, social salience, face processing, Electroencephalography (EEG)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxytocinDrug

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

  • PlaceboOther

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

Study groups in NCT03096249
Study groupRoleWhat they receive
OxytocinExperimentalSyntocinon 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)
Receives: Drug: Oxytocin
PlaceboPlacebo comparatorPhysiological water (sodium chloride (NaCl) solution) Administration via nasal spray
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: random: 30-70 minutes after nasal spray

  2. 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)

    Measured: random: 30-70 minutes after nasal spray

  3. 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)

    Measured: random: 30-70 minutes after nasal spray

  4. 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)

    Measured: random: 30-70 minutes after nasal spray

Secondary outcomes (6)

  1. 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

    Measured: 80 minutes after nasal spray (after all EEG measures)

  2. resting state EEG

    EEG recording, while presenting a fixation cross

    Measured: 45-50 minutes after nasal spray (after two FPVS paradigms)

  3. 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.

    Measured: Baseline

  4. Social phobia: Social Phobia Inventory (SPIN)

    A 17-item questionnaire that screens for, and measures, the severity of social anxiety disorder.

    Measured: Baseline

  5. 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).

    Measured: Baseline

  6. 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).

    Measured: 90 minutes after nasal spray

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2017
  2. Study start21 Nov 2016
  3. Primary completion30 May 2017
  4. Study completion30 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03096249
Sponsor's protocol ID
SingleOT_EEG_S56327
Status last verified
Jul 2022
First submitted
7 Mar 2017
Last updated
22 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Tomescu MI, Van der Donck S, Perisanu EM, Berceanu AI, Alaerts K, Boets B, Carcea I. Social functioning predicts individual changes in EEG microstates following intranasal oxytocin administration: A double-blind, cross-over randomized clinical trial. Psychophysiology. 2024 Aug;61(8):e14581. doi: 10.1111/psyp.14581. Epub 2024 Apr 9.

    PubMed 38594888

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Oxytocin in people with Oxytocin, run by KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

social salience frequency-tagging FPVS (time frame: random: 30-70 minutes after nasal spray). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03096249, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.

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