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Effects of Serotonin Agonist Citalopram on Multimodal Esophageal Stimulation in Healthy Volunteers

Primary Purpose

Gastroesophageal Reflux

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Citalopram
Placebo
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gastroesophageal Reflux

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • HV aged between 18 - 60 years

Exclusion Criteria:

  • history of psychiatric disease or a positive first degree psychiatric family history
  • pregnancy or lactation
  • concomitant administration of any centrally activating medication (anti-depressive medication, hypnotics, sedatives, anxiolytics, …)
  • medication affecting esophageal motility
  • significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic)
  • prior history of esophageal, gastric surgery or endoscopic anti-reflux procedure
  • history of gastrointestinal disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Citalopram

    Placebo

    Arm Description

    Administration of citalopram to assess the esophageal sensitivity in HV

    Administration of placebo to assess the esophageal sensitivity in HV

    Outcomes

    Primary Outcome Measures

    Change in sensitivity to thermal stimulation
    To detect changes in thermal stimulation for sensitivity

    Secondary Outcome Measures

    Change in sensitivity to mechanical stimulation
    To detect changes in mechanical stimulation for sensitivity
    Change in sensitivity to electrical stimulation
    To detect changes in electrical stimulation for sensitivity
    Change in sensitivity to chemical stimulation
    To detect changes in chemical stimulation for sensitivity
    Change in positive and negative affect score
    To detect change in affect of the multimodal stimulation using the PANAS = Positive and Negative Affect scale that consists of two 10-item scales to measure both positive and negative affect. Higher score on the Positive scale is better; Higher score on the Negative Affect scale is worse.
    Change in state trait and anxiety score
    to detect changes in the score due to the multimodal stimulation using the The State-Trait Anxiety Inventory (STAI). Each type of anxiety has its own scale of 20 different questions that are scored.Scores range from 20 to 80, with higher scores correlating with greater anxiety.

    Full Information

    First Posted
    April 15, 2020
    Last Updated
    April 20, 2020
    Sponsor
    Universitaire Ziekenhuizen KU Leuven
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04355455
    Brief Title
    Effects of Serotonin Agonist Citalopram on Multimodal Esophageal Stimulation in Healthy Volunteers
    Official Title
    Effects of Serotonin Agonist Citalopram on Multimodal Esophageal Stimulation in Healthy Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2011 (Actual)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    January 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitaire Ziekenhuizen KU Leuven

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To investigate the effect of citalopram, a selective serotonin reuptake inhibitor, on esophageal sensitivity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroesophageal Reflux

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Citalopram
    Arm Type
    Active Comparator
    Arm Description
    Administration of citalopram to assess the esophageal sensitivity in HV
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Administration of placebo to assess the esophageal sensitivity in HV
    Intervention Type
    Drug
    Intervention Name(s)
    Citalopram
    Intervention Description
    40 mg citalopram intravenously
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Saline solution
    Primary Outcome Measure Information:
    Title
    Change in sensitivity to thermal stimulation
    Description
    To detect changes in thermal stimulation for sensitivity
    Time Frame
    After 1 hour 30 minutes after administration citalopram, we will start with the thermal stimulation
    Secondary Outcome Measure Information:
    Title
    Change in sensitivity to mechanical stimulation
    Description
    To detect changes in mechanical stimulation for sensitivity
    Time Frame
    After 1 hour 45 minutes after administration citalopram, we will start with the mechanical stimulation
    Title
    Change in sensitivity to electrical stimulation
    Description
    To detect changes in electrical stimulation for sensitivity
    Time Frame
    After 2 hours after administration citalopram, we will start with the electrical stimulation
    Title
    Change in sensitivity to chemical stimulation
    Description
    To detect changes in chemical stimulation for sensitivity
    Time Frame
    After 2 hours 15 minutes after administration citalopram, we will start with the chemical stimulation
    Title
    Change in positive and negative affect score
    Description
    To detect change in affect of the multimodal stimulation using the PANAS = Positive and Negative Affect scale that consists of two 10-item scales to measure both positive and negative affect. Higher score on the Positive scale is better; Higher score on the Negative Affect scale is worse.
    Time Frame
    At the beginning of the study and at the end of the multimodal stimulation
    Title
    Change in state trait and anxiety score
    Description
    to detect changes in the score due to the multimodal stimulation using the The State-Trait Anxiety Inventory (STAI). Each type of anxiety has its own scale of 20 different questions that are scored.Scores range from 20 to 80, with higher scores correlating with greater anxiety.
    Time Frame
    At the beginning of the study and at the end of the multimodal stimulation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: HV aged between 18 - 60 years Exclusion Criteria: history of psychiatric disease or a positive first degree psychiatric family history pregnancy or lactation concomitant administration of any centrally activating medication (anti-depressive medication, hypnotics, sedatives, anxiolytics, …) medication affecting esophageal motility significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic) prior history of esophageal, gastric surgery or endoscopic anti-reflux procedure history of gastrointestinal disease

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Serotonin Agonist Citalopram on Multimodal Esophageal Stimulation in Healthy Volunteers

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