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

N/ACompletedNCT04355455

Universitaire Ziekenhuizen KU Leuven14 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Gastroesophageal Reflux

Interventions

CitalopramDRUG

40 mg citalopram intravenously

PlaceboDRUG

Saline solution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in sensitivity to thermal stimulation

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 Outcomes

Change in sensitivity to mechanical stimulation

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

Change in sensitivity to electrical stimulation

To detect changes in electrical stimulation for sensitivity

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

Change in sensitivity to chemical stimulation

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

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.

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

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.