OxytocinPhase 1/2NCT03272321
Influence of Oxytocin on Neurophysiological Responses to Live Faces
A Phase 1/2 study testing Oxytocin in people with Oxytocin, run by KU Leuven at 1 site in Belgium.
Trial summary
Previous research has indicated that direct eye gaze compared to averted gaze, elicits a higher skin conductance response (SCR), and a more pronounced left frontal cortex activity than right frontal cortex activity (resulting in positive asymmetry scores). Read more about this study
- Who is it for?
- Ages 18 to 35 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
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Jul 2017to 18 May 2018
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- right-handed
- male
- age between 18 and 35
- Normal or adjusted-to-normal vision (with lenses only)
- Dutch as mother tongue
Who cannot join
- not right-handed
- female
- age below 18 or above 35
- Need to wear glasses
- Dutch not as mother tongue
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Oxytocin on Neurophysiological Responses to Direct and Averted Gaze
Previous research has indicated that direct eye gaze compared to averted gaze, elicits a higher skin conductance response (SCR), and a more pronounced left frontal cortex activity than right frontal cortex activity (resulting in positive asymmetry scores). On a behavioral level, participants tend to look shorter at live faces with a direct gaze as compared to averted gaze (Akechi et al., 2013). Further, subjective evaluations showed that a direct gaze is rated more arousing and less pleasant than an averted gaze (Akechi et al., 2013; Hietanen, Leppänen, Peltola, Linna-aho, \& Ruuhiala, 2008).
Importantly, oxytocin administration increases the number of fixations and to looking time towards the eye region during live social interaction. Further, oxytocin has been shown to influence SCR and heart rate variability. Therefore, it is conceivable that oxytocin will not only influence the gaze duration of the participant, but also the physiological and neurological responses elicited by direct eye gaze.
In this study, the investigators will investigate whether oxytocin modulates the behavioural (eye gaze and subjective ratings), neurological (EEG) and physiological (skin conductance, heart rate and respiration) responses elicited by direct gaze.
Read the detailed description
Previous research has indicated that direct eye gaze compared to averted gaze, elicits a higher skin conductance response (SCR), and a more pronounced left frontal cortex activity than right frontal cortex activity (resulting in positive asymmetry scores). On a behavioral level, participants tend to look shorter at live faces with a direct gaze as compared to averted gaze (Akechi et al., 2013). Further, subjective evaluations showed that a direct gaze is rated more arousing and less pleasant than an averted gaze (Akechi et al., 2013; Hietanen, Leppänen, Peltola, Linna-aho, \& Ruuhiala, 2008).
Importantly, oxytocin administration increases the number of fixations and to looking time towards the eye region during live social interaction. Further, oxytocin has been shown to influence SCR and heart rate variability. Therefore, it is conceivable that oxytocin will not only influence the gaze duration of the participant, but also the physiological and neurological responses elicited by direct eye gaze.
In this randomized, placebo controlled, double blinded study, the investigators will investigate whether oxytocin modulates the behavioral and neurophysiological responses elicited by direct gaze. In order to do so, the investigators will measure behavioural (eye gaze and subjective feelings), physiological (skin conductance, blood volume pulse, and respiration) and neurological (EEG) responses during presentations of a live person's face with direct gaze and closed eyes, before and after oxytocin or placebo administration.
The investigators hypotheses that oxytocin attenuates the heightened SCR and pronounced EEG asymmetry during direct gaze. Further, they expect that oxytocin increases the number of fixations and duration of those fixations towards the eye region. Exploratory, the investigators will also investigate whether oxytocin administration influences respiration and the subjective reports on experience of live eye contact. Lastly (and also exploratory), they will explore whether certain personality traits (as measured by SAAM (state adult attachment measure) and SRS (social responsiveness scale)) influence the modulatory effect of oxytocin on neurological and behavioural responses.
Note that this study is part of a larger study in which the investigators also register several neurophysiological responses (blood volume pulse, respiration, heart rate, EEG, skin conductance) during rest before and after oxytocin or placebo administration.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called syntocinon
Syntocinon nasal spray
PlaceboDrug
Placebo nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | Syntocinon nasal spray (40 IU/ml; oxytocin, product code RVG 03716); single intranasal dose of 24 international units (IU; 3 puffs of 4 IU per nostril) Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | saline natriumchloride solution nasal spray; single intranasal dose (3 puffs per nostril) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EEG asymmetry after oxytocin administration
The influence of oxytocin administration on EEG asymmetry
Measured: Average over several trials, baseline and 40 min after oxytocin or placebo administration
Change in skin conductance (type of electrodermal activity) response after oxytocin administration
The influence of oxytocin administration on skin conductance response
Measured: Average over several trials, baseline and 40 min after oxytocin or placebo administration
Secondary outcomes (2)
Change in duration of fixations to face regions after oxytocin administration
The influence of oxytocin administration on gaze behavior (duration of fixation to upper and lower face regions)
Measured: Assesment over several trials, baseline and 40 min after oxytocin or placebo administration
Change in number of fixations to face regions after oxytocin administration
The influence of oxytocin administration on gaze behavior (number of fixation to upper and lower face regions)
Measured: Assesment over several trials, baseline and 40 min after oxytocin or placebo administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start24 Jul 2017
- Primary completion18 May 2018
- Study completion18 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OxytocinStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Principal investigator, Kaat Alaerts, KU Leuven
- Investigators
- Kaat Alaerts, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272321
- Sponsor's protocol ID
- SingleOT_EEG-SC_S56327
- Status last verified
- Jul 2019
- First submitted
- 25 Aug 2017
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Oxytocin on Neurophysiological Responses to Direct and Averted Gaze
- ClinicalTrials.gov ID
- NCT03272321
- Acronym / sponsor ID
- SingleOT_EEG-SC_S56327
- Conditions
- Oxytocin
- Keywords
- biomedical intervention, oxytocin, EEG, skin conductance response, heart rate, gaze direction, eye contact
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 18 May 2018 (actual)
- Study completion
- 18 May 2018 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous research has indicated that direct eye gaze compared to averted gaze, elicits a higher skin conductance response (SCR), and a more pronounced left frontal cortex activity than right frontal cortex activity (resulting in positive asymmetry scores). On a behavioral level, participants tend to look shorter at live faces with a direct gaze as compared to averted gaze (Akechi et al., 2013). Further, subjective evaluations showed that a direct gaze is rated more arousing and less pleasant than an averted gaze (Akechi et al., 2013; Hietanen, Leppänen, Peltola, Linna-aho, \& Ruuhiala, 2008).
Importantly, oxytocin administration increases the number of fixations and to looking time towards the eye region during live social interaction. Further, oxytocin has been shown to influence SCR and heart rate variability. Therefore, it is conceivable that oxytocin will not only influence the gaze duration of the participant, but also the physiological and neurological responses elicited by direct eye gaze.
In this study, the investigators will investigate whether oxytocin modulates the behavioural (eye gaze and subjective ratings), neurological (EEG) and physiological (skin conductance, heart rate and respiration) responses elicited by direct gaze.
Detailed description
Previous research has indicated that direct eye gaze compared to averted gaze, elicits a higher skin conductance response (SCR), and a more pronounced left frontal cortex activity than right frontal cortex activity (resulting in positive asymmetry scores). On a behavioral level, participants tend to look shorter at live faces with a direct gaze as compared to averted gaze (Akechi et al., 2013). Further, subjective evaluations showed that a direct gaze is rated more arousing and less pleasant than an averted gaze (Akechi et al., 2013; Hietanen, Leppänen, Peltola, Linna-aho, \& Ruuhiala, 2008).
Importantly, oxytocin administration increases the number of fixations and to looking time towards the eye region during live social interaction. Further, oxytocin has been shown to influence SCR and heart rate variability. Therefore, it is conceivable that oxytocin will not only influence the gaze duration of the participant, but also the physiological and neurological responses elicited by direct eye gaze.
In this randomized, placebo controlled, double blinded study, the investigators will investigate whether oxytocin modulates the behavioral and neurophysiological responses elicited by direct gaze. In order to do so, the investigators will measure behavioural (eye gaze and subjective feelings), physiological (skin conductance, blood volume pulse, and respiration) and neurological (EEG) responses during presentations of a live person's face with direct gaze and closed eyes, before and after oxytocin or placebo administration.
The investigators hypotheses that oxytocin attenuates the heightened SCR and pronounced EEG asymmetry during direct gaze. Further, they expect that oxytocin increases the number of fixations and duration of those fixations towards the eye region. Exploratory, the investigators will also investigate whether oxytocin administration influences respiration and the subjective reports on experience of live eye contact. Lastly (and also exploratory), they will explore whether certain personality traits (as measured by SAAM (state adult attachment measure) and SRS (social responsiveness scale)) influence the modulatory effect of oxytocin on neurological and behavioural responses.
Note that this study is part of a larger study in which the investigators also register several neurophysiological responses (blood volume pulse, respiration, heart rate, EEG, skin conductance) during rest before and after oxytocin or placebo administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: OxytocinSyntocinon nasal spray (40 IU/ml; oxytocin, product code RVG 03716); single intranasal dose of 24 international units (IU; 3 puffs of 4 IU per nostril) |
| Placebo | Placebo comparator | Drug: Placebosaline natriumchloride solution nasal spray; single intranasal dose (3 puffs per nostril) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- right-handed
- male
- age between 18 and 35
- Normal or adjusted-to-normal vision (with lenses only)
- Dutch as mother tongue
Key exclusion criteria (5 listed)
- not right-handed
- female
- age below 18 or above 35
- Need to wear glasses
- Dutch not as mother tongue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: syntocinonSyntocinon nasal spray | Drug | Oxytocin |
| PlaceboPlacebo nasal spray | Drug | Placebo |
Primary outcome
Change in EEG asymmetry after oxytocin administration
Time frame: Average over several trials, baseline and 40 min after oxytocin or placebo administration
The influence of oxytocin administration on EEG asymmetry
Change in skin conductance (type of electrodermal activity) response after oxytocin administration
Time frame: Average over several trials, baseline and 40 min after oxytocin or placebo administration
The influence of oxytocin administration on skin conductance response
2 secondary outcomes
Change in duration of fixations to face regions after oxytocin administration
Time frame: Assesment over several trials, baseline and 40 min after oxytocin or placebo administration
Change in number of fixations to face regions after oxytocin administration
Time frame: Assesment over several trials, baseline and 40 min after oxytocin or placebo administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaat Alaerts, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
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 5 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 1 Aug 2019. 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?
Change in EEG asymmetry after oxytocin administration (time frame: Average over several trials, baseline and 40 min after oxytocin or placebo administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2019.