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临床试验/NCT04867304
NCT04867304已完成不适用

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

Asian Institute of Gastroenterology, India1 个研究点 分布在 1 个国家目标入组 625 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
625
试验地点
1
主要终点
Improvement in Quality of life parameters

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-60yrs
  • Both genders
  • Documented CP for at least 3 years
  • Capable and willing to provide informed consent

排除标准

  • 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

结局指标

主要结局

Improvement in Quality of life parameters

时间窗: 3 months

Measured by the EORTC-QLQc30 + PAN28

Improvement in depression scores

时间窗: 3 months

Measured by the BDI II score

Change in brain metabolite profiles

时间窗: 3 months

Measured by using Magnetic resonance spectroscopy

次要结局

未报告次要终点

研究者

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rupjyoti Talukdar

Director, Pancreas Clinic; Head, Pancreas Research Group

Asian Institute of Gastroenterology, India

研究点 (1)

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