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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06113029
Other study ID # Depression and liver
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date October 1, 2024

Study information

Verified date November 2023
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this observational study is to learn about the prevalence of depressive and anxiety disorders among patients with chronic liver diseases


Description:

Major depressive disorder (MDD), or clinical depression, is a psychiatric disorder characterized by 2 or more weeks of persistently depressed mood accompanied by symptoms such as feelings of worthlessness, guilt, hopelessness, helplessness, loss of self-esteem, sleep disturbance, changes in oral intake, anhedonia, loss of interest, and suicidality. The american psychiatric association, on the definition of anxiety, describes anxiety as the anticipated anticipation of a future danger or negative event, accompanied by feelings of dysphoria or physical symptoms of tension. The elements exposed to risk may belong both to the internal world and to the external world. depression is highly prevalent globally and is a leading cause of disability. The global burden of disease study found depression to be a leading cause of disability among all illnesses. Liver cirrhosis is one of the diseases commonly associated with depression.chronic liver disease is the progressive destruction and regeneration of the liver parenchyma leading to fibrosis and cirrhosis (normally lasts 6 months). The etiologic agents of CLD include hepatotropic viruses (HBV and HCV), fatty liver, alcohol, autoimmune hepatitis, etc. The mortality of CLD patients remains high not only due to irreversible cirrhosis, but also multiple complications such as HCC and mental disease, especially depression. The progressive nature of this disease results in high rates of hospitalization, extensive exposure to medications, increased financial burden, frequent need for invasive procedures, changes in body image, and an increase in morbidity and mortality. All these factors contribute to the physical and psychological stress that mediates the development of depressive symptom high rates of depression have been documented in patients with decompensated liver disease and in those anticipating liver transplantation.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 118
Est. completion date October 1, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: 1. patients admitted or attending at Rajhi university hospital with chronic liver disease including: viral (hepatitis B and C), autoimmune (primary biliary cirrhosis, primary sclerosing cholangitis and autoimmune hepatitis), non-alcoholic steatohepatitis, Morbus Wilson and cryptogenic CLD. 2. age group above 18 years old. Exclusion Criteria: 1. patients with chronic liver disease with other psychiatric disorders other than depression and anxiety. 2. patients with acute complication of chronic liver disease. 3. patients with chronic liver disease who underwent liver transplation. 4. patients with chronic liver disease under antiviral therapy.

Study Design


Intervention

Diagnostic Test:
The Hamilton Rating Scale for Anxiety
The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
The Beck Depression inventory
one of the most widely used instruments for measuring the severity of depression
Rand SF-36 Questionnaire
The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Component analyses showed that there are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS). All scales do contribute in different proportions to the scoring of both PCS and MCS measures

Locations

Country Name City State
Egypt Salma Ashraf Mohamed Badr Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Huang X, Liu X, Yu Y. Depression and Chronic Liver Diseases: Are There Shared Underlying Mechanisms? Front Mol Neurosci. 2017 May 8;10:134. doi: 10.3389/fnmol.2017.00134. eCollection 2017. — View Citation

Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593. Erratum In: Arch Gen Psychiatry. 2005 Jul;62(7):768. Merikangas, Kathleen R [added]. — View Citation

Vahia VN. Diagnostic and statistical manual of mental disorders 5: A quick glance. Indian J Psychiatry. 2013 Jul;55(3):220-3. doi: 10.4103/0019-5545.117131. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants that experienced depressive or anxiety disorders Each participant will be asked to fill items of questionnaires like The Beck Depression inventor, The Hamilton Rating Scale for Anexity and Rand SF-36 Questionnaire Baseline
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