Functional Chest PainPhase 4Ci-FCPNCT05735756
Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain
A Phase 4 study testing Citalopram 20mg in people with Functional Chest Pain, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Chest Pain
- What is being tested?
- Citalopram 20mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Jan 2022to 22 Apr 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105AZ
About this study
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.
Read the 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.
- Conditions
- Functional Chest Pain
- Being tested
- Citalopram 20mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citalopram 20mgDrug
Citalopram 20mg once a day for 12 weeks
PlaceboDrug
Placebo once a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Citalopram 20mg | Active comparator | Not described Receives: Drug: Citalopram 20mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks after start of the study
Secondary outcomes (7)
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.
Measured: 12 weeks after start of the study
Symptom frequency
Patients are asked to report the frequency of symptom episodes on a daily base
Measured: 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).
Measured: 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
Measured: 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
Measured: Baseline, 6 weeks and 12 weeks
Psychological comorbidity using the Hospital Anxiety and Depression Scale (HADS)
Psychological comorbidity is assessed every 6 weeks
Measured: Baseline, 6 weeks and 12 weeks
Adverse events/side effects
Patients are asked to report adverse events and side effects.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start17 Jan 2022
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Why it stopped: The clinical trial has ended prematurely due to low patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Chest PainStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.dr. A.J. (Arjan) Bredenoord, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735756
- Sponsor's protocol ID
- NL77673.018.21
- Acronym
- Ci-FCP
- Status last verified
- Feb 2023
- First submitted
- 26 Jan 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain
- ClinicalTrials.gov ID
- NCT05735756
- Acronym / sponsor ID
- Ci-FCP / NL77673.018.21
- Conditions
- Functional Chest Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The clinical trial has ended prematurely due to low patient recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citalopram 20mg | Active comparator | Drug: Citalopram 20mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citalopram 20mgCitalopram 20mg once a day for 12 weeks | Drug | Citalopram 20mg |
| PlaceboPlacebo once a day for 12 weeks | Drug | Placebo |
Primary outcome
Global assessment of patient reported change in chest pain after 6 weeks of treatment.
Time frame: 6 weeks after start of the study
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.
7 secondary outcomes
Global assessment of patient reported change in chest pain after 12 weeks of treatment.
Time frame: 12 weeks after start of the study
Symptom frequency
Time frame: Daily diary during the entire duration of the study (12 weeks)
Symptom severity
Time frame: 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)
Time frame: Baseline, 6 weeks and 12 weeks
Health related quality of life measured using 36-Item Short Form Health Survey (SF36)
Time frame: Baseline, 6 weeks and 12 weeks
Psychological comorbidity using the Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 6 weeks and 12 weeks
Adverse events/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.
Results and safety
The study was stopped early (reason given: The clinical trial has ended prematurely due to low patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Citalopram 20mg in people with Functional Chest Pain, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The clinical trial has ended prematurely due to low patient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global assessment of patient reported change in chest pain after 6 weeks of treatment. (time frame: 6 weeks after start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.