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

NCT ID: NCT04355455

Last Updated: 2020-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-01-31

Brief Summary

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

Detailed Description

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Conditions

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Gastroesophageal Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Citalopram

Administration of citalopram to assess the esophageal sensitivity in HV

Group Type ACTIVE_COMPARATOR

Citalopram

Intervention Type DRUG

40 mg citalopram intravenously

Placebo

Administration of placebo to assess the esophageal sensitivity in HV

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline solution

Interventions

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Citalopram

40 mg citalopram intravenously

Intervention Type DRUG

Placebo

Saline solution

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Prof Dr Jan Tack

Prof Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Citalopram MuMoS HV

Identifier Type: -

Identifier Source: org_study_id

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