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OpenTrials
Completed

NCT Number: NCT04355455

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

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

Completed

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Citalopram

Drug

40 mg citalopram intravenously

Placebo

Drug

Saline solution

Primary outcomes

  1. Change in sensitivity to thermal stimulation

    Time frame: After 1 hour 30 minutes after administration citalopram, we will start with the thermal stimulation

    To detect changes in thermal stimulation for sensitivity

Secondary outcomes

  1. Change in sensitivity to mechanical stimulation

    Time frame: After 1 hour 45 minutes after administration citalopram, we will start with the mechanical stimulation

    To detect changes in mechanical stimulation for sensitivity

  2. Change in sensitivity to electrical stimulation

    Time frame: After 2 hours after administration citalopram, we will start with the electrical stimulation

    To detect changes in electrical stimulation for sensitivity

  3. Change in sensitivity to chemical stimulation

    Time frame: After 2 hours 15 minutes after administration citalopram, we will start with the chemical stimulation

    To detect changes in chemical stimulation for sensitivity

  4. Change in positive and negative affect score

    Time frame: At the beginning of the study and at the end of the multimodal stimulation

    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.

  5. Change in state trait and anxiety score

    Time frame: At the beginning of the study and at the end of the multimodal stimulation

    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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Apr 21, 2020
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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