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.

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux
• Intervention / Treatment: Drug: Placebo; Drug: Citalopram

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: Citalopram MuMoS HV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No