Basic ScienceNCT04443647
Influence of Oxytocin on Approach-avoidance Tendencies to Social and Non-social Stimuli
A study testing Oxytocin in people with Basic Science, run by KU Leuven at 1 site in Belgium.
Trial summary
In this study, a randomized, placebo-controlled between-subject design is adopted to investigate the effect of a single-dose of intranasally administered OT on approach-avoidance related motivational tendencies during the processing of a series of social and non-social, positively and negatively valenced stimuli. 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
- Basic Science
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Dec 2018to 30 Jan 2020
- Phase
- Interventional
- 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
- female
- age below 18 or above 35
- neurological or psychiatric condition (e.g. epilepsy, stroke, concussion), (e.g. anxiety disorder, depression)
- use of psychotropic medication (e.g. anxiolytics, antidepressants)
Trial locations and contacts
1 site in 1 country.
About this study
In this study, a randomized, placebo-controlled between-subject design is adopted to investigate the effect of a single-dose of intranasally administered OT on approach-avoidance related motivational tendencies during the processing of a series of social and non-social, positively and negatively valenced stimuli. To obtain a behavioral measure of approach-avoidance tendencies, participants will be able to control the viewing time of the presented stimuli, by pressing 'up' or 'down' on a keyboard. During stimulus presentation neurophysiological recordings will be performed to obtain a neural measure of approach-avoidance motivational tendencies, based on electroencephalographic recordings (EEG: frontal alpha asymmetry). Also assessments of autonomic arousal, based on skin conductance recordings will be collected.
Read the detailed description
The neuropeptide oxytocin (OT) plays an important role in a wide-range of complex social behaviors. Recently however, the 'social' specificity of OT's action has been challenged, considering several observations of non-social effects of OT showing for example that OT reliably reduces stress also in non-social tasks.
To account for these non-social effects of OT, the General Approach-Avoidance Hypothesis of OT (GAAO) has been put forward, positing that OT primarily modulates approach/ avoidance motivational tendencies and behaviors by impacting on the mesocorticolimbic circuitry linked to reward (approach) as well as cortico-amygdala circuits linked to threat (avoidance) (Harari-Dahan and Bernstein, 2014). Since the neural substrates underlying 'social' approach and avoidance are not distinct from those underlying 'non-social' approach and avoidance, the GAAO posits that the modulatory effects of OT should not be limited to social behaviors. In this view, the GAAO puts forward that OT may indeed enhance the attentional salience of many social cues, but not because they are social per se; but because many social stimuli are emotionally-evocative and personally-relevant.
In this study, a randomized, placebo-controlled between-subject design is adopted to investigate the effect of a single-dose of intranasally administered OT on approach-avoidance related motivational tendencies during the processing of a series of social and non-social, positively and negatively valenced stimuli. To obtain a behavioral measure of approach-avoidance tendencies, participants will be able to control the viewing time of the presented stimuli, by pressing 'up' or 'down' on a keyboard. During stimulus presentation neurophysiological recordings will be performed to obtain a neural measure of approach-avoidance motivational tendencies, based on electroencephalographic recordings (EEG: frontal alpha asymmetry). Also electrodermal recordings (skin conductance) will be collected to obtain assessments of sympathetically-driven autonomic arousal.
In accordance to the GAAO account, it is hypothesized that OT will reduce avoidance-related motivational tendencies (assessed behaviorally and using EEG), irrespective of sociality (i.e. similar effect towards social and non-social stimuli).
In accordance to prior research, skin conductance responses are hypothesized to reduce after OT, indicating reduced sympathetically-driven autonomic arousal. On the other hand, considering the implicated role of sympathetic arousal in orienting responses, OT might also facilitate an enhancement of skin conductance responses, i.e., being reflective of OT's role in enhancing salience toward emotionally-evocative stimuli.
- Conditions
- Basic Science
- Being tested
- Oxytocin, Placebo
- Keywords
- oxytocin, sociality, approach-avoidance motivational tendencies, EEG frontal assymmetry, skin conductance, autonomic arousal
- Medical subject headings
- Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
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 frontal alpha asymmetry after nasal spray administration
The influence of oxytocin administration on EEG frontal alpha asymmetry
Measured: Average over trials, baseline and approximately 30 minutes after nasal spray administration
Change in behavioral approach-avoidance (number of up or down key presses, prolonging or shortening the viewing time towards presented stimuli)
During the presentation of a series of stimuli, participants will be able to prolong or shorten the viewing time towards the presented stimuli, by pressing an 'up' or 'down' key on a keyboard. The number of up versus down key-presses will be taken as a measure of behavioral approach-avoidance.
The influence of oxytocin administration on the number of up or down key presses will be assessed.
Measured: Average over trials, baseline and approximately 30 minutes after nasal spray administration
Change in skin conductance (type of electrodermal recording) after nasal spray administration
The influence of oxytocin adminstration on skin conductance
Measured: Average over trials, baseline and approximately 30 minutes after nasal spray administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start15 Dec 2018
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Basic ScienceStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaat Alaerts, KU Leuven
- Investigators
- Kaat Alaerts, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443647
- Sponsor's protocol ID
- SingleOT_EEG-App-avoid_S56327
- Status last verified
- Jun 2020
- First submitted
- 17 Jun 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data will be made availabe to other researchers upon reasonable request.
Publications
Harari-Dahan O, Bernstein A. A general approach-avoidance hypothesis of oxytocin: accounting for social and non-social effects of oxytocin. Neurosci Biobehav Rev. 2014 Nov;47:506-19. doi: 10.1016/j.neubiorev.2014.10.007.
PubMed 25454355Alaerts K, Taillieu A, Daniels N, Soriano JR, Prinsen J. Oxytocin enhances neural approach towards social and non-social stimuli of high personal relevance. Sci Rep. 2021 Dec 8;11(1):23589. doi: 10.1038/s41598-021-02914-8.
PubMed 34880300
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Oxytocin on Approach-avoidance Tendencies to Social and Non-social Stimuli
- ClinicalTrials.gov ID
- NCT04443647
- Acronym / sponsor ID
- SingleOT_EEG-App-avoid_S56327
- Conditions
- Basic Science
- Keywords
- oxytocin, sociality, approach-avoidance motivational tendencies, EEG frontal assymmetry, skin conductance, autonomic arousal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 23 Jun 2020 (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.
In this study, a randomized, placebo-controlled between-subject design is adopted to investigate the effect of a single-dose of intranasally administered OT on approach-avoidance related motivational tendencies during the processing of a series of social and non-social, positively and negatively valenced stimuli. To obtain a behavioral measure of approach-avoidance tendencies, participants will be able to control the viewing time of the presented stimuli, by pressing 'up' or 'down' on a keyboard. During stimulus presentation neurophysiological recordings will be performed to obtain a neural measure of approach-avoidance motivational tendencies, based on electroencephalographic recordings (EEG: frontal alpha asymmetry). Also assessments of autonomic arousal, based on skin conductance recordings will be collected.
Detailed description
The neuropeptide oxytocin (OT) plays an important role in a wide-range of complex social behaviors. Recently however, the 'social' specificity of OT's action has been challenged, considering several observations of non-social effects of OT showing for example that OT reliably reduces stress also in non-social tasks.
To account for these non-social effects of OT, the General Approach-Avoidance Hypothesis of OT (GAAO) has been put forward, positing that OT primarily modulates approach/ avoidance motivational tendencies and behaviors by impacting on the mesocorticolimbic circuitry linked to reward (approach) as well as cortico-amygdala circuits linked to threat (avoidance) (Harari-Dahan and Bernstein, 2014). Since the neural substrates underlying 'social' approach and avoidance are not distinct from those underlying 'non-social' approach and avoidance, the GAAO posits that the modulatory effects of OT should not be limited to social behaviors. In this view, the GAAO puts forward that OT may indeed enhance the attentional salience of many social cues, but not because they are social per se; but because many social stimuli are emotionally-evocative and personally-relevant.
In this study, a randomized, placebo-controlled between-subject design is adopted to investigate the effect of a single-dose of intranasally administered OT on approach-avoidance related motivational tendencies during the processing of a series of social and non-social, positively and negatively valenced stimuli. To obtain a behavioral measure of approach-avoidance tendencies, participants will be able to control the viewing time of the presented stimuli, by pressing 'up' or 'down' on a keyboard. During stimulus presentation neurophysiological recordings will be performed to obtain a neural measure of approach-avoidance motivational tendencies, based on electroencephalographic recordings (EEG: frontal alpha asymmetry). Also electrodermal recordings (skin conductance) will be collected to obtain assessments of sympathetically-driven autonomic arousal.
In accordance to the GAAO account, it is hypothesized that OT will reduce avoidance-related motivational tendencies (assessed behaviorally and using EEG), irrespective of sociality (i.e. similar effect towards social and non-social stimuli).
In accordance to prior research, skin conductance responses are hypothesized to reduce after OT, indicating reduced sympathetically-driven autonomic arousal. On the other hand, considering the implicated role of sympathetic arousal in orienting responses, OT might also facilitate an enhancement of skin conductance responses, i.e., being reflective of OT's role in enhancing salience toward emotionally-evocative stimuli.
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 (4 listed)
- female
- age below 18 or above 35
- neurological or psychiatric condition (e.g. epilepsy, stroke, concussion), (e.g. anxiety disorder, depression)
- use of psychotropic medication (e.g. anxiolytics, antidepressants)
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 |
|---|---|---|
| OxytocinSyntocinon nasal spray | Drug | Oxytocin |
| PlaceboPlacebo nasal spray | Drug | Placebo |
Primary outcome
Change in EEG frontal alpha asymmetry after nasal spray administration
Time frame: Average over trials, baseline and approximately 30 minutes after nasal spray administration
The influence of oxytocin administration on EEG frontal alpha asymmetry
Change in behavioral approach-avoidance (number of up or down key presses, prolonging or shortening the viewing time towards presented stimuli)
Time frame: Average over trials, baseline and approximately 30 minutes after nasal spray administration
During the presentation of a series of stimuli, participants will be able to prolong or shorten the viewing time towards the presented stimuli, by pressing an 'up' or 'down' key on a keyboard. The number of up versus down key-presses will be taken as a measure of behavioral approach-avoidance. The influence of oxytocin administration on the number of up or down key presses will be assessed.
Change in skin conductance (type of electrodermal recording) after nasal spray administration
Time frame: Average over trials, baseline and approximately 30 minutes after nasal spray administration
The influence of oxytocin adminstration on skin conductance
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 23 Jun 2020.
- Background: PubMed 25454355Harari-Dahan O, Bernstein A. A general approach-avoidance hypothesis of oxytocin: accounting for social and non-social effects of oxytocin. Neurosci Biobehav Rev. 2014 Nov;47:506-19. doi: 10.1016/j.neubiorev.2014.10.007.
- Derived from this study: PubMed 34880300Alaerts K, Taillieu A, Daniels N, Soriano JR, Prinsen J. Oxytocin enhances neural approach towards social and non-social stimuli of high personal relevance. Sci Rep. 2021 Dec 8;11(1):23589. doi: 10.1038/s41598-021-02914-8.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data will be made availabe to other researchers upon reasonable request.
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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 study testing Oxytocin in people with Basic Science, 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 23 Jun 2020. 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.
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 frontal alpha asymmetry after nasal spray administration (time frame: Average over trials, baseline and approximately 30 minutes after nasal spray administration). The study lists 3 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 NCT04443647, which also lists 2 linked publications.
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 23 Jun 2020.