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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04867304
Enrollment
625
Registered
2021-04-30
Start date
2018-02-01
Completion date
2020-01-31
Last updated
2021-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Chronic Pancreatitis, Depression, Quality of Life

Brief summary

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.

Interventions

OTHERPatient education about chronic pancreatitis.

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.

Sponsors

Asian Institute of Gastroenterology, India
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement in depression scores3 monthsMeasured by the BDI II score
Improvement in Quality of life parameters3 monthsMeasured by the EORTC-QLQc30 + PAN28
Change in brain metabolite profiles3 monthsMeasured by using Magnetic resonance spectroscopy

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026