xml: <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/NCT06014606</url>
    </required_header>
    <id_info>
      <org_study_id>DANE1</org_study_id>
      <nct_id>NCT06014606</nct_id>
    </id_info>
    <brief_title>Learning and Decision-making</brief_title>
    <official_title>How Does the Brain Learn About Positive and Negative Things?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Maastricht University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Maastricht University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        A fundamental aspect of daily life decision-making involves the evaluation of costs and&#xD;
        benefits. Neural systems underlying cost-benefit evaluation have been extensively examined,&#xD;
        but the specific role of different neurotransmitters remains unclear. Numerous studies&#xD;
        suggest that both dopamine (DA) and norepinephrine (NE) are closely related to reinforcement&#xD;
        learning, guided exploration/exploitation, and behavioural energisation, although no studies&#xD;
        to date have investigated the distinct role of DA and NE on cost-benefit decision-making and&#xD;
        learning in human subjects.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2021</start_date>
    <completion_date type="Actual">August 16, 2023</completion_date>
    <primary_completion_date type="Actual">April 30, 2023</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>Double (Participant, Investigator)</masking>
      <masking_description>double-blind (randomised) between-subjects design</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Cost-benefit reinforcement learning performance</measure>
      <time_frame>~ 2.5 hours post-drug administration</time_frame>
      <description>2-choice reinforcement learning task (based on Voulgaropoulou et al., 2021 PNEC)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Effort-based decision-making</measure>
      <time_frame>~ 2 hours post-drug administration</time_frame>
      <description>motivation to acquire rewards (e.g., Reddy et al. 2015)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Physiology I</measure>
      <time_frame>pre, +30 min., +60 min., +90 min., +120 min., +190 min. post-drug administration</time_frame>
      <description>Heart rate</description>
    </other_outcome>
    <other_outcome>
      <measure>Physiology II</measure>
      <time_frame>pre, +30 min., +60 min., +90 min., +120 min., +190 min. post-drug administration</time_frame>
      <description>blood pressure</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">150</enrollment>
    <condition>Motivation</condition>
    <arm_group>
      <arm_group_label>HV/Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Oral placebo (tablet)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HV/Haloperidol</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>2mg (oral)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HV/Propranolol</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>40mg (oral)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>placebo</intervention_name>
      <description>oral formulation</description>
      <arm_group_label>HV/Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>haloperidol 2mg</intervention_name>
      <description>oral formulation</description>
      <arm_group_label>HV/Haloperidol</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>propranolol 40mg</intervention_name>
      <description>oral formulation</description>
      <arm_group_label>HV/Propranolol</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Willingness to sign an informed consent&#xD;
  &#xD;
            -  Age between 18 and 35&#xD;
  &#xD;
            -  Body-Mass Index (BMI) between 17.5-30&#xD;
  &#xD;
            -  Availability for participation through the duration of the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of a psychiatric or neurological disorder, including substance abuse or&#xD;
               dependence (yes/no self-report - lifetime)&#xD;
  &#xD;
            -  Use of any psychopharmacological treatment 3 weeks before the test day (yes/no&#xD;
               self-report)&#xD;
  &#xD;
            -  Use of any blood pressure medication (yes/no self-report - lifetime)&#xD;
  &#xD;
            -  Pregnancy (confirmed via urine pregnancy test) or nursing (yes/no self-report) or have&#xD;
               plans to get pregnant in the near future (yes/no self-report) (females only)&#xD;
  &#xD;
            -  Diagnosis of a cardiac disease (medical questionnaire), obstructive respiratory&#xD;
               disease (medical questionnaire), abnormal blood pressure (diastolic&lt; 60mmHg; systolic&lt;&#xD;
               90mmHg) (medical screening)&#xD;
  &#xD;
            -  Chronic renal failure (medical questionnaire)&#xD;
  &#xD;
            -  Hypothyroidism (medical questionnaire)&#xD;
  &#xD;
            -  Diabetes (medical questionnaire)&#xD;
  &#xD;
            -  Hypersensitivity to phenothiazines (medical questionnaire)&#xD;
  &#xD;
            -  Diagnosis of a cardiac disease (medical questionnaire)&#xD;
  &#xD;
            -  Alcohol consumption in the 24 hours before the test session starts (yes/no&#xD;
               self-report)&#xD;
  &#xD;
            -  Food intake less than 3 hours before the test day (yes/no self-report)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Maastricht University</name>
        <address>
          <city>Maastricht</city>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <results_reference>
      <citation>Voulgaropoulou SD, Fauzani F, Pfirrmann J, Vingerhoets C, van Amelsvoort T, Hernaus D. Asymmetric effects of acute stress on cost and benefit learning. Psychoneuroendocrinology. 2022 Apr;138:105646. doi: 10.1016/j.psyneuen.2021.105646. Epub 2021 Dec 24.</citation>
      <PMID>35065334</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 5, 2022</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Propranolol</mesh_term>
      <mesh_term>Haloperidol</mesh_term>
      <mesh_term>Haloperidol decanoate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06014606
  org study id: DANE1
  nct id: NCT06014606
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  A fundamental aspect of daily life decision-making involves the evaluation of costs and
        benefits. Neural systems underlying cost-benefit evaluation have been extensively examined,
        but the specific role of different neurotransmitters remains unclear. Numerous studies
        suggest that both dopamine (DA) and norepinephrine (NE) are closely related to reinforcement
        learning, guided exploration/exploitation, and behavioural energisation, although no studies
        to date have investigated the distinct role of DA and NE on cost-benefit decision-making and
        learning in human subjects.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: Double (Participant, Investigator)
  masking description: double-blind (randomised) between-subjects design
  measure: Cost-benefit reinforcement learning performance
  time frame: ~ 2.5 hours post-drug administration
  description: 2-choice reinforcement learning task (based on Voulgaropoulou et al., 2021 PNEC)
  measure: Effort-based decision-making
  time frame: ~ 2 hours post-drug administration
  description: motivation to acquire rewards (e.g., Reddy et al. 2015)
  measure: Physiology I
  time frame: pre, +30 min., +60 min., +90 min., +120 min., +190 min. post-drug administration
  description: Heart rate
  measure: Physiology II
  time frame: pre, +30 min., +60 min., +90 min., +120 min., +190 min. post-drug administration
  description: blood pressure
  arm group label: HV/Placebo
  arm group type: Placebo Comparator
  description: Oral placebo (tablet)
  arm group label: HV/Haloperidol
  arm group type: Active Comparator
  description: 2mg (oral)
  arm group label: HV/Propranolol
  arm group type: Active Comparator
  description: 40mg (oral)
  intervention type: Drug
  intervention name: placebo
  description: oral formulation
  arm group label: HV/Placebo
  intervention type: Drug
  intervention name: haloperidol 2mg
  description: oral formulation
  arm group label: HV/Haloperidol
  intervention type: Drug
  intervention name: propranolol 40mg
  description: oral formulation
  arm group label: HV/Propranolol
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Netherlands
  citation: Voulgaropoulou SD, Fauzani F, Pfirrmann J, Vingerhoets C, van Amelsvoort T, Hernaus D. Asymmetric effects of acute stress on cost and benefit learning. Psychoneuroendocrinology. 2022 Apr;138:105646. doi: 10.1016/j.psyneuen.2021.105646. Epub 2021 Dec 24.
  PMID: 35065334
  responsible party type: Sponsor
  mesh term: Propranolol
  mesh term: Haloperidol
  mesh term: Haloperidol decanoate
  sharing ipd: Undecided