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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pancreatitis Behavior Behavioral Symptoms Chronic Disease Chronic Pain Depression Digestive System Diseases Disease Attributes Neurologic Manifestations Pain Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asian Institute of Gastroenterology

Hyderabad, Andhra Pradesh, 500082, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient education about chronic pancreatitis.

Other

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.

Primary outcomes

Improvement in depression scores

Time frame: 3 months

Measured by the BDI II score
Improvement in Quality of life parameters

Time frame: 3 months

Measured by the EORTC-QLQc30 + PAN28
Change in brain metabolite profiles

Time frame: 3 months

Measured by using Magnetic resonance spectroscopy

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Apr 30, 2021
Registry last updated: Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed