Chronic PancreatitisNCT04867304
Determinants of Depression and Its Impact on Quality of Life in Patients With Chronic Pancreatitis
An observational study of Chronic Pancreatitis and Depression, run by Asian Institute of Gastroenterology, India at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pancreatitis, Depression, Quality of Life
- What is being tested?
- Patient education about chronic pancreatitis.
- How many people
- 625 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2018to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
- Inclusion Criteria:
- Age 18-60yrs
- Both genders
- Documented CP for at least 3 years
- Capable and willing to provide informed consent
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Asian Institute of Gastroenterology
Hyderabad, Andhra Pradesh, 500082
About this study
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.
- Conditions
- Chronic Pancreatitis, Depression, Quality of Life, Chronic Pain
- Being tested
- Patient education about chronic pancreatitis.
- Medical subject headings
- Pancreatitis, Chronic, Depression, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patient education about chronic pancreatitis. | |
| Chronic pancreatitis with depression | This group contains patients with CP who has depression based on the Beck Depression inventory. Receives: Other: Patient education about chronic pancreatitis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in depression scores
Measured by the BDI II score
Measured: 3 months
Improvement in Quality of life parameters
Measured by the EORTC-QLQc30 + PAN28
Measured: 3 months
Change in brain metabolite profiles
Measured by using Magnetic resonance spectroscopy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start1 Feb 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 625 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupjyoti Talukdar, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867304
- Sponsor's protocol ID
- AIG-DEPCP-01
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Depression and Its Impact on Quality of Life in Patients With Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT04867304
- Acronym / sponsor ID
- AIG-DEPCP-01
- Conditions
- Chronic Pancreatitis, Depression, Quality of Life, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 625 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Patient education about chronic pancreatitis.This group contains patients with CP who does not have depression based on the Beck Depression inventory. |
| Chronic pancreatitis with depression | – | Other: Patient education about chronic pancreatitis.This group contains patients with CP who has depression based on the Beck Depression inventory. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Chronic pancreatitis with depression, Chronic pancreatitis without depression |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
Related trials for Chronic Pancreatitis
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis and Depression, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in depression scores (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.