Determinants of Depression and Its Impact on Quality of Life in Patients With Chronic Pancreatitis

Study Overview
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Brief Summary
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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. In 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.

Official Title
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Determinants of Depression and Its Impact on Quality of Life in Patients With Chronic Pancreatitis

Conditions
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Quality of Life, Chronic Pain, Chronic Pancreatitis, Depression

Intervention / Treatment
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* Other: Patient education about chronic pancreatitis.


Participation Criteria
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Eligibility Criteria
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A. Inclusion Criteria: Age 18-60yrs Both genders Documented CP for at least 3 years Capable and willing to provide informed consent B. Exclusion Criteria: Acute exacerbation of pancreatitis Pancreatic malignancy On anti-depressant and antipsychotic medications Concomitant psychiatric illness (other than depression) Pancreatic malignancy Major co-morbidities Pregnancy and lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy controls<br>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. | |
| Chronic pancreatitis without depression<br>This group contains patients with CP who does not have depression based on the Beck Depression inventory. | Other: Patient education about chronic pancreatitis.<br>* 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. The patients were advised to visit the Pancreas clinic after 3-months for re-evaluation of the clinical, psychological and metabolic parameters.<br>|
| Chronic pancreatitis with depression<br>This group contains patients with CP who has depression based on the Beck Depression inventory. | Other: Patient education about chronic pancreatitis.<br>* 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. The patients were advised to visit the Pancreas clinic after 3-months for re-evaluation of the clinical, psychological and metabolic parameters.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in depression scores | Measured by the BDI II score | 3 months | 
| Improvement in Quality of life parameters | Measured by the EORTC-QLQc30 + PAN28 | 3 months | 
| Change in brain metabolite profiles | Measured by using Magnetic resonance spectroscopy | 3 months |