Efficacy and Tolerability of Escitalopram for the Prevention of Pegylated Interferon Alfa Associated Depression in Patients With Chronic Hepatitis C Infection: a Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher
研究概览
简要总结
Primary end points
- incidence of depression defined as a Montgomery Asberg Depression Scale Score (MADRS) of 13 or higher during antiviral therapy (up to 48 weeks, depending on genotype)
- effect of an antidepressive pre-treatment over two weeks and a continuously concomitant treatment with Escitalopram (S-citalopram) on frequency and severity of depression in patients with chronic hepatitis C (HCV) treated with Peg-interferon alfa-2a (PEGASYS) and ribavirin, measured by the Montgomery Asberg Depression Scale
Secondary end points
- time to depression defined as a MADRS score of 13 or higher
- incidence of major depression defined by Diagnostic and Statistical Manual IV (DSM-IV) criteria
- severe depression according to MADRS scale (score 25 or higher)
- Health related quality of life (HRQOL) measured by the Short Form 36 (SF-36)
- sustained virologic response
- tolerability
- safety
- changes/group differences in other psychiatric depression scales (Hamilton Depression Rating Scale, Beck Depression Inventory)
Other investigations:
- cognitive function, anxiety (word fluency test, trail making test part A and B, othe scales)
- Predictive parameters for patients especially gaining from an antidepressive therapy (e.g. age, gender, weight, height, alanine aminotransferase (ALAT) quotient defined as median ALAT values before treatment divided by the upper standard value, HCV-RNA serum concentration level of fibrosis in liver histology, baseline values of the different psychometric scales)
- alanine aminotransferase (ALAT), aspartate transaminase (ASAT), thyrotrophin (TSH)
- biomarkers (genetic parameters, cytokines,...)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis C infection defined as positive anti-HCV antibodies and serum HCV-RNA >1000 IU/ml, naive to antiviral treatment
- •age >18 years
排除标准
- •Antidepressive treatment within the last 3 years
- •Psychiatric diseases including major depressive disorders in past medical history
- •Active substance abuse during the last 12 months
- •Pregnancy, lactation, wish to become pregnant
- •Hepatitis B (HBV)/HIV-coinfection
- •Decompensated liver disease, hepatocellular carcinoma, history of bleeding esophageal varices
- •Neutropenia (<1500/ul), thrombocytopenia (<70/nl), anemia (<12g/dl in females, <13g/dl in males)
- •History of autoimmune disease
- •History of organ transplantation, concomitant liver disease, severe cardiopulmonary disease, hemolytic anemia, malignant disease
研究组 & 干预措施
Escitalopram
After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.
干预措施: Escitalopram (Drug)
Escitalopram
After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.
干预措施: Peginterferon alfa-2a (Drug)
Escitalopram
After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.
干预措施: Ribavirin (Drug)
Placebo
After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.
干预措施: Placebo (Drug)
Placebo
After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.
干预措施: Peginterferon alfa-2a (Drug)
Placebo
After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher
时间窗: 50 weeks for genotypes 1 or 4 and 26 weeks for patients with genotype 2 or 3
Clinically relevant depression (MADRS score of 13 or higher) during antiviral treatment presented as "percentage of participants" with "MADRS scores \> 13" (entire time period: from starting study medication until end of antiviral treatment = 48 weeks in patients with genotype 1 or 4 and 24 weeks for patients with genotype 2 or 3)
次要结局
- Proportion of Patients Without Depression (Defined as a MADRS Score of 13 or Higher)(Patients free of depression during 24 or 48 weeks of antiviral therapy)
- Incidence of Major Depression Defined by Diagnostic and Statistical Manual IV (DSM-IV) Criteria(major depression during 24 or 48 weeks of antiviral therapy)
- Severe Depression Defined as a MADRS Score of 25 or Higher(severe depression during 24 or 48 weeks of antiviral therapy)
- Health Related Quality of Life (HRQOL) Measured by the Short Form 36 (SF-36)(assessed 2,4,12,24 and 48 weeks of antiviral treatment)
- Sustained Virologic Response(assessed 24 weeks after end of antiviral treatment)
- Tolerability(assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment)
- Safety(assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment)
研究者
M. Schaefer, MD
Martin Schaefer, MD
Charite University, Berlin, Germany