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

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

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

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Drug: Citalopram
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Citalopram<br>Administration of citalopram to assess the esophageal sensitivity in HV | Drug: Citalopram<br>* 40 mg citalopram intravenously<br>|
| Placebo Comparator: Placebo<br>Administration of placebo to assess the esophageal sensitivity in HV | Drug: Placebo<br>* Saline solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sensitivity to thermal stimulation | To detect changes in thermal stimulation for sensitivity | After 1 hour 30 minutes after administration citalopram, we will start with the thermal stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sensitivity to mechanical stimulation | To detect changes in mechanical stimulation for sensitivity | 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 | 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 | 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. | 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. | At the beginning of the study and at the end of the multimodal stimulation |