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

NCT05735756 | Terminated Phase 4 DMC

• 1 other identifier: NL77673.018.21
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Chest Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Global assessment of patient reported change in chest pain after 12 weeks of treatment.

  12 weeks after start of the study

• Symptom frequency

  Daily diary during the entire duration of the study (12 weeks)

• Symptom severity

  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)

  Baseline, 6 weeks and 12 weeks

• Health related quality of life measured using 36-Item Short Form Health Survey (SF36)

  Baseline, 6 weeks and 12 weeks

Study Arms (2)

Citalopram 20mg

ACTIVE COMPARATOR

Drug: Citalopram 20mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Citalopram 20mg DRUG

Citalopram 20mg once a day for 12 weeks

Citalopram 20mg

Placebo DRUG

Placebo once a day for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Interventions

Citalopram

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 21, 2023
• Study Start: January 17, 2022
• Primary Completion: April 22, 2022
• Study Completion: April 22, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)