CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 385 enrolled
Drug / intervention
Depression and Cognitive Testsother
Likely dose
Not stated in record
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Search/NCT04330508
NCT04330508N/ACompleted

Effects of Direct-acting Antiviral Agents on Cognitive Function, and Depression in Chronic Hepatitis C

Post Graduate Institute of Medical Education and Research, Chandigarh·observational·Posted Apr 1, 2020·Updated Feb 13, 2024

In Brief

An observational study evaluating Depression and Cognitive Tests for Depression in Chronic Hepatitis C. Completed, enrolled 385 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 1, 2020
Enrollment StartMar 1, 2018
Primary CompletionOct 31, 2021
Study CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 6.3 years ago

Interventions

Depression and Cognitive Testsother

Health Related Quality of Life, neurocognitive tests, PHES