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

NCT04355455 | Completed

• 1 other identifier: Citalopram MuMoS HV
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in sensitivity to mechanical stimulation

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

• Change in sensitivity to electrical stimulation

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

• Change in sensitivity to chemical stimulation

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

• Change in positive and negative affect score

  At the beginning of the study and at the end of the multimodal stimulation

• Change in state trait and anxiety score

  At the beginning of the study and at the end of the multimodal stimulation

Study Arms (2)

Citalopram

ACTIVE COMPARATOR

Administration of citalopram to assess the esophageal sensitivity in HV

Drug: Citalopram

Placebo

PLACEBO COMPARATOR

Administration of placebo to assess the esophageal sensitivity in HV

Drug: Placebo

Interventions

Citalopram DRUG

40 mg citalopram intravenously

Citalopram

Placebo DRUG

Saline solution

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• HV aged between 18 - 60 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 21, 2020
• Study Start: July 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share