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

Sponsor
Asian Institute of Gastroenterology, India (Other)
Overall Status
Completed
CT.gov ID
NCT04867304
Collaborator
(none)
625
1
24
26.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Patient education about chronic pancreatitis.

Study Design

Study Type:
Observational
Actual Enrollment :
625 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Determinants of Depression and Its Impact on Quality of Life in Patients With Chronic Pancreatitis
Actual Study Start Date :
Feb 1, 2018
Actual Primary Completion Date :
Jan 31, 2020
Actual Study Completion Date :
Jan 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Healthy controls

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

This group contains patients with CP who does not have depression based on the Beck Depression inventory.

Other: Patient 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.

Chronic pancreatitis with depression

This group contains patients with CP who has depression based on the Beck Depression inventory.

Other: Patient 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.

Outcome Measures

Primary Outcome Measures

  1. Improvement in depression scores [3 months]

    Measured by the BDI II score

  2. Improvement in Quality of life parameters [3 months]

    Measured by the EORTC-QLQc30 + PAN28

  3. Change in brain metabolite profiles [3 months]

    Measured by using Magnetic resonance spectroscopy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asian Institute of Gastroenterology Hyderabad Andhra Pradesh India 500082

Sponsors and Collaborators

  • Asian Institute of Gastroenterology, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rupjyoti Talukdar, Director, Pancreas Clinic; Head, Pancreas Research Group, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier:
NCT04867304
Other Study ID Numbers:
  • AIG-DEPCP-01
First Posted:
Apr 30, 2021
Last Update Posted:
Apr 30, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 30, 2021