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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Quality of Life; Chronic Pain; Chronic Pancreatitis
• Intervention / Treatment: Other: Patient education about chronic pancreatitis.

• Study Type: Observational
• Enrollment (Actual): 625

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500082
      • Asian Institute of Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Digestive System Diseases; Mood Disorders; Pain; Neurologic Manifestations; Pancreatic Diseases; Depression; Depressive Disorder; Chronic Pain; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: AIG-DEPCP-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No