Gastroesophageal Reflux
Conditions
Brief summary
To investigate the effect of citalopram, a selective serotonin reuptake inhibitor, on esophageal sensitivity.
Interventions
DRUGCitalopram
40 mg citalopram intravenously
DRUGPlacebo
Saline solution
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sensitivity to thermal stimulation | After 1 hour 30 minutes after administration citalopram, we will start with the thermal stimulation | To detect changes in thermal stimulation for sensitivity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sensitivity to mechanical stimulation | After 1 hour 45 minutes after administration citalopram, we will start with the mechanical stimulation | To detect changes in mechanical stimulation for sensitivity |
| Change in sensitivity to electrical stimulation | After 2 hours after administration citalopram, we will start with the electrical stimulation | To detect changes in electrical stimulation for sensitivity |
| Change in sensitivity to chemical stimulation | After 2 hours 15 minutes after administration citalopram, we will start with the chemical stimulation | To detect changes in chemical stimulation for sensitivity |
| Change in positive and negative affect score | At the beginning of the study and at the end of the multimodal stimulation | 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. |
| Change in state trait and anxiety score | At the beginning of the study and at the end of the multimodal stimulation | 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. |
Outcome results
None listed