Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain (Ci-FCP)

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.

Study Overview

• Status: Terminated
• Conditions: Functional Chest Pain
• Intervention / Treatment: Drug: Citalopram 20mg; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105AZ
      • Amsterdam UMC, location AMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo once a day for 12 weeks
Active Comparator: Citalopram 20mg	Drug: Citalopram 20mg; Citalopram 20mg once a day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global assessment of patient reported change in chest pain after 6 weeks of treatment.	Patients will be asked; "Compared to the start of the treatment, how would you rate the chest pain now?; Completely resolved; Moderately better; Slightly better; No change; Slightly worse; Moderately worse; Much worse Patients who answered completely resolved or moderately better will be defined as treatment success.	6 weeks after start of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global assessment of patient reported change in chest pain after 12 weeks of treatment.	Patients will be asked; "Compared to the start of the treatment, how would you rate the chest pain now?; Completely resolved; Moderately better; Slightly better; No change; Slightly worse; Moderately worse; Much worse Patients who answered completely resolved or moderately better will be defined as treatment success.	12 weeks after start of the study
Symptom frequency	Patients are asked to report the frequency of symptom episodes on a daily base	Daily diary during the entire duration of the study (12 weeks)
Symptom severity	Patients are asked to report the severity of every symptom episode on a daily base. The severity will be rated on a 4-point scale: mild (1, the symptom was well tolerated and did not last long) moderate (2, the symptom caused some discomfort, but did not interfere with usual activities), severe (3, the symptom caused a great deal of discomfort, and interfered with usual activities), disabling (4, the symptom was unbearable and interfered considerably with usual activities).	Daily diary during the entire duration of the study (12 weeks)
Chest pain will be scored on a 0-10 visual analog scale (VAS-score)	Patients are asked to report the severity of the chest pain every 6 weeks	Baseline, 6 weeks and 12 weeks
Health related quality of life measured using 36-Item Short Form Health Survey (SF36)	The health related quality of life is measured every 6 weeks	Baseline, 6 weeks and 12 weeks
Psychological comorbidity using the Hospital Anxiety and Depression Scale (HADS)	Psychological comorbidity is assessed every 6 weeks	Baseline, 6 weeks and 12 weeks
Adverse events/side effects	Patients are asked to report adverse events and side effects.	Adverse event reporting period is defined as the period following time of written informed consent up to 3 months after end of the observation period.

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Actual): April 22, 2022
• Study Completion (Actual): April 22, 2022

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Estimate): February 20, 2023

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chest Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: NL77673.018.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No