Depression in Chronic Hepatitis C Clinical Trial
Official title:
Effects of Direct-acting Antiviral Agents on Cognitive Function, and Depression in Chronic Hepatitis C
| Verified date | February 2024 |
| Source | Postgraduate Institute of Medical Education and Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Minimal hepatic encephalopathy (MHE) is an important clinical variant of hepatic encephalopathy (HE), which occurs in up to 60-70% of patients with cirrhosis. The condition comprises a cognitive impairment, observed in patients with cirrhosis who have no clinical evidence of overt hepatic encephalopathy (OHE). It is associated with an increased incidence of road traffic accidents, reduced quality of life and it affects the ability to perform tasks of daily living. Successful treatment of hepatitis C has been reported to be associated with 62-84% reduction in all-cause mortality (deaths), 68-79% reduction in risk of HCC and 90% reduction in risk of liver transplantation. In addition, studies have shown that viral eradication may improve cognition when given interferon based regimens for HCV. With the available of safe, efficacious, all oral regimens for HCV, we plan to prospectively analyse the change in mood, depression and cognitive function in response to DAA therapy, in relation to outcomes of treatment.
| Status | Completed |
| Enrollment | 385 |
| Est. completion date | December 31, 2021 |
| Est. primary completion date | October 31, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - Age 18-65 years and chronic HCV infection. - Group A: Patients with hepatitis C (Non-cirrhotic) [n= 150] - Group B: Patients with hepatitis C related compensated-cirrhosis [n= 150] - Group C: Healthy volunteers [n= 25] Exclusion Criteria: - Current overt hepatic encephalopathy or during the last 1 month - TIPS (transjugular intra- hepatic porto-systemic shunt) - elective surgery planned within the next 8 weeks - unable to give informed consent - HIV infection - chronic respiratory insufficiency - current infection and receiving antibiotics - renal failure (serum creatinine = 1.5 mg/l) - hepatocellular carcinoma, - patient with other neurological disease - intake of sedatives, antidepressants, benzodiazepines, or benzodiazepines-antagonists (flumazenil, neuromuscular blocking agents) |
| Country | Name | City | State |
|---|---|---|---|
| India | Postgraduate Institute of Medical Education and Research | Chandigarh |
| Lead Sponsor | Collaborator |
|---|---|
| Postgraduate Institute of Medical Education and Research |
India,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cognitive performance | Computerized battery (Reaction times, simple and choice, visual memory, Number connection test, and Inhibitory Control Test) | Day 0 | |
| Primary | Cognitive performance | Computerized battery (Reaction times, simple and choice, visual memory, Number connection test, and Inhibitory Control Test) | 90 days after treatment completion | |
| Primary | Cognitive performance using conventional tests | Psychometric hepatic encephalopathy score (PHES), Indian Version. | Day 0 | |
| Primary | Cognitive performance using conventional tests | Psychometric hepatic encephalopathy score (PHES), Indian Version. | 90 days after treatment completion | |
| Primary | HRQOL by SF-36 | Day 0 | ||
| Primary | HRQOL by SF-36 | 90 days after treatment completion | ||
| Secondary | Depression Scale | Beck's Depression Inventory (BDI) Generalized anxiety disorder (GAD 7 score) Psychometric hepatic encephalopathy Score (PHES) Montreal Cognitive assessment Score (MoCA Score) | Day 0 | |
| Secondary | Depression Scale | Beck's Depression Inventory (BDI) Generalized anxiety disorder (GAD 7 score) Psychometric hepatic encephalopathy Score (PHES) Montreal Cognitive assessment Score (MoCA Score) | 90 days after treatment completion |