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

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355455
• Other study ID #: Citalopram MuMoS HV
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: January 2012

Study information

• Verified date: April 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• Citalopram
40 mg citalopram intravenously
• Placebo
Saline solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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