Psychobiological Characterization of Depression in Hepatitis C
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
The aim of this study is to do an evaluation of the clinical profile of depression in HCV patients (newly diagnosed and treatment naïve), and in these same individuals, 24 weeks after the beginning of IFN+Ribavirin therapeutics (n=100). To characterize depression associated to HCV with and without interferon (IFN), the investigators will use clinical, behavioral, biochemical and genetic markers, and to distinguish their different symptomatologic dimensions.
The control group will be composed by 100 individuals with Major Depression diagnosis, and not from the general population, because the investigators are not trying to study the incidence of depression in general population, but to characterize the clinical profile of patients with HCV (IFN+Ribavirin) compared to major depression.
Thus, the investigators will total 300 evaluations in 200 individuals, 100 from each group, and considering that the clinical group will be evaluated before the therapeutics and re-evaluated 24 weeks after its beginning.
Hypotheses
- Depression in individuals affected by HCV is associated to genetic vulnerability.
- Genetic vulnerability increases the risk of depression when IFN therapeutics is used.
- Depression associated to infection by HCV presents a symptomatological profile that is different from general depression, which is maintained with IFN therapeutics.
- A higher state of depression in the beginning of a treatment, if not treated, is a risk factor to abandoning therapeutics.
- When comparing genders, women present a more severe symptomatological profile than men.
详细描述
The World Health Organization (WHO) estimates that about 3% of the world population (170 million people) is infected with the hepatitis C virus (HCV). In Portugal, there were an estimated 150.000 cases, of which only 10% have confirmed diagnosis. The disease's potential of evolution towards chronicity, hepatic cirrhosis and hepatocellular carcinoma, makes this the main indicator for liver transplant. Besides the natural history of this disease and the burden that it causes in the economy, these individuals frequently present neuropsychiatric symptoms like fatigue, anxiety, depression and cognitive disorders.
Among these, depression stands out for its enormous impact on individuals and society. Reaching higher than 15%, this will be the second most prevailing disease in the world by 2020, according to WHO predictions.
Regarding neuropsychiatric symptoms, one can identify two distinctive patterns in its relation with HCV infection. On one hand, individuals with chronic hepatitis C have higher prevalence of psychiatric disorders, including depression. On the other hand, individuals with psychiatric records present higher HCV infection rates than the average population.
A combined therapeutics of pegylated interferon (IFN) and ribavirin is used in these patients as the standard treatment, and proves to be a fundamental and consensual intervention for a favorable change in the natural history of the disease. However, this treatment is associated with a high number of adverse reactions like: "influenza-like" symptoms, irritability, insomnia, fatigue and loss of appetite. Apart from these, neuropsychiatric symptoms (specially depression, and sometimes with suicidal ideation), are among the most common secondary effects in therapeutics with IFN, being one of the main causes why patients interrupt their treatment. It is noteworthy that, up to a certain extent, psychopathologic symptoms (depression, cognitive disorders) may be associated to HCV infection, even without an interferon treatment, and may be related to direct HCV neurotoxicity.
This symptomatology negatively affects the individual's perceived quality of life, its general functioning, work capacities, overall well-being and quality of life. Furthermore, therapeutic used in HCV treatment is associated to impairment in all of these dimensions.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •minimum education;
- •ages between 18 and 65 years old;
- •with diagnosis of Hepatitis C for at least 6 months, newly diagnosed and treatment naive;
- •and diagnosis of Major Depression for the control group.
排除标准
- •consumption of opiates, cocaine or other recreational drugs in the 6 months prior to the beginning of the research;
- •use of anti-inflammatory drugs and antidepressants;
- •history of neurological, infectious or tumoral pathology, at SNC level;
- •severe physical deterioration incompatible with the situation being evaluated.
研究者
David Pires Barreira
Dr.
Centro Hospitalar Lisboa Norte