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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04867304
• Other study ID #: AIG-DEPCP-01
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: April 2021
• Source: Asian Institute of Gastroenterology, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 625
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pancreatitis
• Depression
• Depressive Disorder
• Pancreatitis
• Pancreatitis, Chronic
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
India	Asian Institute of Gastroenterology	Hyderabad	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in depression scores	Measured by the BDI II score	3 months
Primary	Improvement in Quality of life parameters	Measured by the EORTC-QLQc30 + PAN28	3 months
Primary	Change in brain metabolite profiles	Measured by using Magnetic resonance spectroscopy	3 months