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

Primary Purpose

Functional Chest Pain

Status
Terminated
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Citalopram 20mg
Placebo
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Chest Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Amsterdam UMC, location AMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Citalopram 20mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Symptom frequency
Patients are asked to report the frequency of symptom episodes on a daily base
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).
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
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
Psychological comorbidity using the Hospital Anxiety and Depression Scale (HADS)
Psychological comorbidity is assessed every 6 weeks
Adverse events/side effects
Patients are asked to report adverse events and side effects.

Full Information

First Posted
January 26, 2022
Last Updated
February 9, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT05735756
Brief Title
Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain
Acronym
Ci-FCP
Official Title
Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
The clinical trial has ended prematurely due to low patient recruitment
Study Start Date
January 17, 2022 (Actual)
Primary Completion Date
April 22, 2022 (Actual)
Study Completion Date
April 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Chest Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Citalopram 20mg
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Citalopram 20mg
Intervention Description
Citalopram 20mg once a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once a day for 12 weeks
Primary Outcome Measure Information:
Title
Global assessment of patient reported change in chest pain after 6 weeks of treatment.
Description
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.
Time Frame
6 weeks after start of the study
Secondary Outcome Measure Information:
Title
Global assessment of patient reported change in chest pain after 12 weeks of treatment.
Description
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.
Time Frame
12 weeks after start of the study
Title
Symptom frequency
Description
Patients are asked to report the frequency of symptom episodes on a daily base
Time Frame
Daily diary during the entire duration of the study (12 weeks)
Title
Symptom severity
Description
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).
Time Frame
Daily diary during the entire duration of the study (12 weeks)
Title
Chest pain will be scored on a 0-10 visual analog scale (VAS-score)
Description
Patients are asked to report the severity of the chest pain every 6 weeks
Time Frame
Baseline, 6 weeks and 12 weeks
Title
Health related quality of life measured using 36-Item Short Form Health Survey (SF36)
Description
The health related quality of life is measured every 6 weeks
Time Frame
Baseline, 6 weeks and 12 weeks
Title
Psychological comorbidity using the Hospital Anxiety and Depression Scale (HADS)
Description
Psychological comorbidity is assessed every 6 weeks
Time Frame
Baseline, 6 weeks and 12 weeks
Title
Adverse events/side effects
Description
Patients are asked to report adverse events and side effects.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Amsterdam UMC, location AMC
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105AZ
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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