<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04443647</url>
  </required_header>
  <id_info>
    <org_study_id>SingleOT_EEG-App-avoid_S56327</org_study_id>
    <nct_id>NCT04443647</nct_id>
  </id_info>
  <brief_title>Influence of Oxytocin on Approach-avoidance Tendencies to Social and Non-social Stimuli</brief_title>
  <official_title>Influence of Oxytocin on Approach-avoidance Tendencies to Social and Non-social Stimuli</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, a randomized, placebo-controlled between-subject design is adopted to&#xD;
      investigate the effect of a single-dose of intranasally administered OT on approach-avoidance&#xD;
      related motivational tendencies during the processing of a series of social and non-social,&#xD;
      positively and negatively valenced stimuli. To obtain a behavioral measure of&#xD;
      approach-avoidance tendencies, participants will be able to control the viewing time of the&#xD;
      presented stimuli, by pressing 'up' or 'down' on a keyboard. During stimulus presentation&#xD;
      neurophysiological recordings will be performed to obtain a neural measure of&#xD;
      approach-avoidance motivational tendencies, based on electroencephalographic recordings (EEG:&#xD;
      frontal alpha asymmetry). Also assessments of autonomic arousal, based on skin conductance&#xD;
      recordings will be collected.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The neuropeptide oxytocin (OT) plays an important role in a wide-range of complex social&#xD;
      behaviors. Recently however, the 'social' specificity of OT's action has been challenged,&#xD;
      considering several observations of non-social effects of OT showing for example that OT&#xD;
      reliably reduces stress also in non-social tasks.&#xD;
&#xD;
      To account for these non-social effects of OT, the General Approach-Avoidance Hypothesis of&#xD;
      OT (GAAO) has been put forward, positing that OT primarily modulates approach/ avoidance&#xD;
      motivational tendencies and behaviors by impacting on the mesocorticolimbic circuitry linked&#xD;
      to reward (approach) as well as cortico-amygdala circuits linked to threat (avoidance)&#xD;
      (Harari-Dahan and Bernstein, 2014). Since the neural substrates underlying 'social' approach&#xD;
      and avoidance are not distinct from those underlying 'non-social' approach and avoidance, the&#xD;
      GAAO posits that the modulatory effects of OT should not be limited to social behaviors. In&#xD;
      this view, the GAAO puts forward that OT may indeed enhance the attentional salience of many&#xD;
      social cues, but not because they are social per se; but because many social stimuli are&#xD;
      emotionally-evocative and personally-relevant.&#xD;
&#xD;
      In this study, a randomized, placebo-controlled between-subject design is adopted to&#xD;
      investigate the effect of a single-dose of intranasally administered OT on approach-avoidance&#xD;
      related motivational tendencies during the processing of a series of social and non-social,&#xD;
      positively and negatively valenced stimuli. To obtain a behavioral measure of&#xD;
      approach-avoidance tendencies, participants will be able to control the viewing time of the&#xD;
      presented stimuli, by pressing 'up' or 'down' on a keyboard. During stimulus presentation&#xD;
      neurophysiological recordings will be performed to obtain a neural measure of&#xD;
      approach-avoidance motivational tendencies, based on electroencephalographic recordings (EEG:&#xD;
      frontal alpha asymmetry). Also electrodermal recordings (skin conductance) will be collected&#xD;
      to obtain assessments of sympathetically-driven autonomic arousal.&#xD;
&#xD;
      In accordance to the GAAO account, it is hypothesized that OT will reduce avoidance-related&#xD;
      motivational tendencies (assessed behaviorally and using EEG), irrespective of sociality&#xD;
      (i.e. similar effect towards social and non-social stimuli).&#xD;
&#xD;
      In accordance to prior research, skin conductance responses are hypothesized to reduce after&#xD;
      OT, indicating reduced sympathetically-driven autonomic arousal. On the other hand,&#xD;
      considering the implicated role of sympathetic arousal in orienting responses, OT might also&#xD;
      facilitate an enhancement of skin conductance responses, i.e., being reflective of OT's role&#xD;
      in enhancing salience toward emotionally-evocative stimuli.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 15, 2018</start_date>
  <completion_date type="Actual">January 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in EEG frontal alpha asymmetry after nasal spray administration</measure>
    <time_frame>Average over trials, baseline and approximately 30 minutes after nasal spray administration</time_frame>
    <description>The influence of oxytocin administration on EEG frontal alpha asymmetry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in behavioral approach-avoidance (number of up or down key presses, prolonging or shortening the viewing time towards presented stimuli)</measure>
    <time_frame>Average over trials, baseline and approximately 30 minutes after nasal spray administration</time_frame>
    <description>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.&#xD;
The influence of oxytocin administration on the number of up or down key presses will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in skin conductance (type of electrodermal recording) after nasal spray administration</measure>
    <time_frame>Average over trials, baseline and approximately 30 minutes after nasal spray administration</time_frame>
    <description>The influence of oxytocin adminstration on skin conductance</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Basic Science</condition>
  <arm_group>
    <arm_group_label>Oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline natriumchloride solution nasal spray; single intranasal dose (3 puffs per nostril)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>Syntocinon nasal spray</description>
    <arm_group_label>Oxytocin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo nasal spray</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  right-handed&#xD;
&#xD;
          -  male&#xD;
&#xD;
          -  age between 18 and 35&#xD;
&#xD;
          -  Normal or adjusted-to-normal vision (with lenses only)&#xD;
&#xD;
          -  Dutch as mother tongue&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  female&#xD;
&#xD;
          -  age below 18 or above 35&#xD;
&#xD;
          -  neurological or psychiatric condition (e.g. epilepsy, stroke, concussion), (e.g.&#xD;
             anxiety disorder, depression)&#xD;
&#xD;
          -  use of psychotropic medication (e.g. anxiolytics, antidepressants)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kaat Alaerts, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KU Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>25454355</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Kaat Alaerts</investigator_full_name>
    <investigator_title>Prof. dr.</investigator_title>
  </responsible_party>
  <keyword>oxytocin</keyword>
  <keyword>sociality</keyword>
  <keyword>approach-avoidance motivational tendencies</keyword>
  <keyword>EEG frontal assymmetry</keyword>
  <keyword>skin conductance</keyword>
  <keyword>autonomic arousal</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>De-identified individual participant data will be made availabe to other researchers upon reasonable request.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04443647
org study id: SingleOT_EEG-App-avoid_S56327
nct id: NCT04443647
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
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
description: The influence of oxytocin administration on EEG frontal alpha asymmetry
measure: 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
description: 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.
measure: 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
description: The influence of oxytocin adminstration on skin conductance
arm group label: Oxytocin
arm group type: Experimental
description: 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)
arm group label: Placebo
arm group type: Placebo Comparator
description: Saline natriumchloride solution nasal spray; single intranasal dose (3 puffs per nostril)
intervention type: Drug
intervention name: Oxytocin
description: Syntocinon nasal spray
arm group label: Oxytocin
intervention type: Drug
intervention name: Placebo
description: Placebo nasal spray
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kaat Alaerts, PhD
role: Principal Investigator
affiliation: KU Leuven
facility: 
country: Belgium
citation: 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.
PMID: 25454355
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Kaat Alaerts
investigator title: Prof. dr.
mesh term: Oxytocin
sharing ipd: Undecided
ipd description: De-identified individual participant data will be made availabe to other researchers upon reasonable request.