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

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Drug: Citalopram; Drug: Placebo

• Registration Number: NCT04355455
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-20
• Last Update Submitted: 2020-04-20
• Study First Posted: 2020-04-21
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Citalopram	Citalopram	Administration of citalopram to assess the esophageal sensitivity in HV
Placebo	Placebo	Administration of placebo to assess the esophageal sensitivity in HV

Primary Outcome Measures

Name	Time	Method
Change in sensitivity to thermal stimulation	After 1 hour 30 minutes after administration citalopram, we will start with the thermal stimulation	To detect changes in thermal stimulation for sensitivity

Secondary Outcome Measures

Name	Time	Method
Change in state trait and anxiety score	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.
Change in sensitivity to electrical stimulation	After 2 hours after administration citalopram, we will start with the electrical stimulation	To detect changes in electrical stimulation for sensitivity
Change in sensitivity to mechanical stimulation	After 1 hour 45 minutes after administration citalopram, we will start with the mechanical stimulation	To detect changes in mechanical stimulation for sensitivity
Change in sensitivity to chemical stimulation	After 2 hours 15 minutes after administration citalopram, we will start with the chemical stimulation	To detect changes in chemical stimulation for sensitivity
Change in positive and negative affect score	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.