Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT04867304
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2021-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determinants of Depression and Its Impact on Quality of Life in Patients With Chronic Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050500', 'term': 'Pancreatitis, Chronic'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 625}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-29', 'studyFirstSubmitDate': '2021-04-27', 'studyFirstSubmitQcDate': '2021-04-29', 'lastUpdatePostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in depression scores', 'timeFrame': '3 months', 'description': 'Measured by the BDI II score'}, {'measure': 'Improvement in Quality of life parameters', 'timeFrame': '3 months', 'description': 'Measured by the EORTC-QLQc30 + PAN28'}, {'measure': 'Change in brain metabolite profiles', 'timeFrame': '3 months', 'description': 'Measured by using Magnetic resonance spectroscopy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pancreatitis', 'Depression', 'Quality of Life', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': 'Chronic pancreatitis (CP) is associated with recurrent intractable abdominal pain, pancreatic exocrine insufficiency and endocrine dysfunction. Very few studies had evaluated the quality of life in CP, and even a fewer have assessed the mental status in these patients.\n\nIn the current study, we proposed to evaluate the the relationship between pain, quality of life and depression status in two large independent cohorts of patients with CP. We also proposed to evaluate the brain metabolites in the right and left anterior cingulate cortex, basal ganglia, hippocampus and prefrontal cortex using magnetic resonance spectroscopy. We further proposed to evaluate the pasta metabolites and look for associations with the mental state. Finally, we proposed to evaluate how CP related education of the patients could impact on their mental status and response to interventions on pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population constitutes of patients with chronic pancreatic of at least 3 years duration. They are a composite with or without depression. Rationale for taking a lag time of at least 3 years was to allow development of the complications of the disease.', 'healthyVolunteers': True, 'eligibilityCriteria': 'A. Inclusion Criteria:\n\n* Age 18-60yrs\n* Both genders\n* Documented CP for at least 3 years\n* Capable and willing to provide informed consent\n\nB. Exclusion Criteria:\n\n* Acute exacerbation of pancreatitis\n* Pancreatic malignancy\n* On anti-depressant and antipsychotic medications\n* Concomitant psychiatric illness (other than depression)\n* Pancreatic malignancy\n* Major co-morbidities\n* Pregnancy and lactation'}, 'identificationModule': {'nctId': 'NCT04867304', 'briefTitle': 'Determinants of Depression and Its Impact on Quality of Life in Patients With Chronic Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Asian Institute of Gastroenterology, India'}, 'officialTitle': 'Determinants of Depression and Its Impact on Quality of Life in Patients With Chronic Pancreatitis', 'orgStudyIdInfo': {'id': 'AIG-DEPCP-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy controls', 'description': 'Individuals without any known illnesses and normal labs./USG w/a. This group was used to compare baseline depression, magnetic resonance spectroscopy and plasma metabolites.'}, {'label': 'Chronic pancreatitis without depression', 'description': 'This group contains patients with CP who does not have depression based on the Beck Depression inventory.', 'interventionNames': ['Other: Patient education about chronic pancreatitis.']}, {'label': 'Chronic pancreatitis with depression', 'description': 'This group contains patients with CP who has depression based on the Beck Depression inventory.', 'interventionNames': ['Other: Patient education about chronic pancreatitis.']}], 'interventions': [{'name': 'Patient education about chronic pancreatitis.', 'type': 'OTHER', 'description': 'Patients in the second cohort were educated about their disease phenotype in a structured and personalised manner that included their disease course, symptoms, imaging, treatment option and possible long-term outcomes and prognosis. This was followed by answering all the queries of the patient and their caregivers.\n\nThe patients were advised to visit the Pancreas clinic after 3-months for re-evaluation of the clinical, psychological and metabolic parameters.', 'armGroupLabels': ['Chronic pancreatitis with depression', 'Chronic pancreatitis without depression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500082', 'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Asian Institute of Gastroenterology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asian Institute of Gastroenterology, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Pancreas Clinic; Head, Pancreas Research Group', 'investigatorFullName': 'Rupjyoti Talukdar', 'investigatorAffiliation': 'Asian Institute of Gastroenterology, India'}}}}