Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04443647
Other study ID # SingleOT_EEG-App-avoid_S56327
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 15, 2018
Est. completion date January 30, 2020

Study information

Verified date June 2020
Source KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date January 30, 2020
Est. primary completion date January 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- right-handed

- male

- age between 18 and 35

- Normal or adjusted-to-normal vision (with lenses only)

- Dutch as mother tongue

Exclusion Criteria:

- 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Oxytocin
Syntocinon nasal spray
Placebo
Placebo nasal spray

Locations

Country Name City State
Belgium KU Leuven Leuven

Sponsors (1)

Lead Sponsor Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in EEG frontal alpha asymmetry after nasal spray administration The influence of oxytocin administration on EEG frontal alpha asymmetry Average over trials, baseline and approximately 30 minutes after nasal spray administration
Primary 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.
Average over trials, baseline and approximately 30 minutes after nasal spray administration
Primary Change in skin conductance (type of electrodermal recording) after nasal spray administration The influence of oxytocin adminstration on skin conductance Average over trials, baseline and approximately 30 minutes after nasal spray administration
See also
  Status Clinical Trial Phase
Completed NCT01860287 - The Effects of Buprenorphine on Responses to Verbal Tasks Early Phase 1
Recruiting NCT05079516 - Neural Basis of Sensory Learning: Brain Regions N/A
Recruiting NCT05953038 - LSD Occupancy of the Serotonin 2A Receptor in the Human Brain Early Phase 1
Completed NCT03541473 - Phosphate Metabolites in Brain of Humans Aged 50+ N/A
Recruiting NCT03289949 - The Neurobiological Effect of 5-HT2AR Modulation Phase 1
Recruiting NCT05739994 - Frontal and Parietal Contributions to Proprioception and Motor Skill Learning N/A
Recruiting NCT05374460 - Factors Affecting Sensory and Motor Learning N/A
Recruiting NCT05124301 - Neural Basis of Sensory and Motor Learning: Functional Connections N/A