Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-02 @ 5:44 AM
Study NCT ID:
NCT05735756
Status:
TERMINATED
Last Update Posted:
2023-02-21
First Post:
2022-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015283', 'term': 'Citalopram'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'The clinical trial has ended prematurely due to low patient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2022-01-26', 'studyFirstSubmitQcDate': '2023-02-09', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global assessment of patient reported change in chest pain after 6 weeks of treatment.', 'timeFrame': '6 weeks after start of the study', 'description': 'Patients will be asked; "Compared to the start of the treatment, how would you rate the chest pain now?\n\n* Completely resolved\n* Moderately better\n* Slightly better\n* No change\n* Slightly worse\n* Moderately worse\n* Much worse Patients who answered completely resolved or moderately better will be defined as treatment success.'}], 'secondaryOutcomes': [{'measure': 'Global assessment of patient reported change in chest pain after 12 weeks of treatment.', 'timeFrame': '12 weeks after start of the study', 'description': 'Patients will be asked; "Compared to the start of the treatment, how would you rate the chest pain now?\n\n* Completely resolved\n* Moderately better\n* Slightly better\n* No change\n* Slightly worse\n* Moderately worse\n* Much worse Patients who answered completely resolved or moderately better will be defined as treatment success.'}, {'measure': 'Symptom frequency', 'timeFrame': 'Daily diary during the entire duration of the study (12 weeks)', 'description': 'Patients are asked to report the frequency of symptom episodes on a daily base'}, {'measure': 'Symptom severity', 'timeFrame': 'Daily diary during the entire duration of the study (12 weeks)', 'description': 'Patients are asked to report the severity of every symptom episode on a daily base.\n\nThe 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).'}, {'measure': 'Chest pain will be scored on a 0-10 visual analog scale (VAS-score)', 'timeFrame': 'Baseline, 6 weeks and 12 weeks', 'description': 'Patients are asked to report the severity of the chest pain every 6 weeks'}, {'measure': 'Health related quality of life measured using 36-Item Short Form Health Survey (SF36)', 'timeFrame': 'Baseline, 6 weeks and 12 weeks', 'description': 'The health related quality of life is measured every 6 weeks'}, {'measure': 'Psychological comorbidity using the Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Baseline, 6 weeks and 12 weeks', 'description': 'Psychological comorbidity is assessed every 6 weeks'}, {'measure': 'Adverse events/side effects', 'timeFrame': '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.', 'description': 'Patients are asked to report adverse events and side effects.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Functional Chest Pain']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Minimum age: 18 years\n* Functional chest pain according to Rome IV criteria\n* Ruled out cardiac origin of chest pain\n* ECG with corrected QT interval (QTc) within the normal range (\\<450ms male, \\<460ms female)\n* Symptoms of chest pain for at least 6 months\n* Frequency of symptoms at least once a week\n* Gastroduodenoscopy, high-resolution manometry and 24-hour pH-impedance monitoring need to have been performed recently.\n\nExclusion Criteria:\n\n* Currently using antidepressants\n* Contraindication for the use of SSRI\n* Already tried antidepressants off-label to treat chest pain\n* Known allergy to citalopram\n* Severe and clinically unstable concomitant disease\n* Pregnant, lactating or fertile women (without contraception)'}, 'identificationModule': {'nctId': 'NCT05735756', 'acronym': 'Ci-FCP', 'briefTitle': 'Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain', 'orgStudyIdInfo': {'id': 'NL77673.018.21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Citalopram 20mg', 'interventionNames': ['Drug: Citalopram 20mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Citalopram 20mg', 'type': 'DRUG', 'description': 'Citalopram 20mg once a day for 12 weeks', 'armGroupLabels': ['Citalopram 20mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo once a day for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Amsterdam UMC, location AMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. dr.', 'investigatorFullName': 'Prof.dr. A.J. (Arjan) Bredenoord', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}