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

Completed

• Conditions: Depression; Chronic Pancreatitis; Chronic Pain; Quality of Life
• Interventions: Other: Patient education about chronic pancreatitis.

• Registration Number: NCT04867304
• Lead Sponsor: Asian Institute of Gastroenterology, India

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2021-04
• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-29
• Last Update Submitted: 2021-04-29
• Study First Posted: 2021-04-30
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 625

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic pancreatitis with depression	Patient education about chronic pancreatitis.	This group contains patients with CP who has depression based on the Beck Depression inventory.
Chronic pancreatitis without depression	Patient education about chronic pancreatitis.	This group contains patients with CP who does not have depression based on the Beck Depression inventory.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, Andhra Pradesh, India