Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-17

Study Completion Date

2022-04-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Non-cardiac chest pain (NCCP) in the absence of musculoskeletal abnormalities, major esophageal motor disorders, gastroesophageal reflux or eosinophilic esophagitis is called functional chest pain (FCP). Most likely multiple factors play a role, such as esophageal hypersensitivity and enhanced perception. Citalopram and other antidepressants are proven to be effective in the treatment of functional gastrointestinal disorders such as irritable bowel syndrome. With this trial the investigators want to assess the effect of citalopram on symptoms of chest pain in patients with functional chest pain.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04355455

Gastroesophageal Reflux

COMPLETED NA

Effect of Antidepressants on Back Pain

NCT00018200

Back Pain Sciatica

COMPLETED PHASE2

Specific Effects of Escitalopram on Neuroendocrine Response

NCT00150527

Healthy

COMPLETED

Effects of Intravenous (IV) Citalopram on Emotional Brain Activity in Healthy Young and Elderly Adults

NCT01216449

Healthy Young and Elderly Volunteers

TERMINATED NA

Efficacy of Antidepressants in Chronic Back Pain

NCT00964886

Back Pain

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Chest pain can be divided in cardiac or non-cardiac chest pain (NCCP). To establish the diagnosis NCCP, acute coronary disease has to be ruled out first. NCCP can be caused by functional chest pain (FCP). NCCP in the absence of musculoskeletal abnormalities, major esophageal motor disorders, gastroesophageal reflux or eosinophilic esophagitis is called FCP. The pathophysiology is not fully understood. Most likely multiple factors play a role, such as esophageal hypersensitivity and enhanced perception. Citalopram and other antidepressants are proven to be effective in the treatment of functional gastrointestinal disorders such as irritable bowel syndrome. However, available data regarding low dose antidepressants in functional chest pain is inconclusive. Moreover, all current evidence concerning the effect of low dose antidepressants in patients with functional chest pain is extracted from trials that pooled patients with different functional esophageal disorders. With this trial the investigators want to assess the effect of citalopram on symptoms of chest pain in patients with functional chest pain.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Functional Chest Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Citalopram 20mg

Group Type ACTIVE_COMPARATOR

Citalopram 20mg

Intervention Type DRUG

Citalopram 20mg once a day for 12 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo once a day for 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Citalopram 20mg

Citalopram 20mg once a day for 12 weeks

Intervention Type DRUG

Placebo

Placebo once a day for 12 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Written informed consent
* Minimum age: 18 years
* Functional chest pain according to Rome IV criteria
* Ruled out cardiac origin of chest pain
* ECG with corrected QT interval (QTc) within the normal range (\<450ms male, \<460ms female)
* Symptoms of chest pain for at least 6 months
* Frequency of symptoms at least once a week
* Gastroduodenoscopy, high-resolution manometry and 24-hour pH-impedance monitoring need to have been performed recently.

Exclusion Criteria

* Currently using antidepressants
* Contraindication for the use of SSRI
* Already tried antidepressants off-label to treat chest pain
* Known allergy to citalopram
* Severe and clinically unstable concomitant disease
* Pregnant, lactating or fertile women (without contraception)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No