The Effect of Duloxetine on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 主要终点
- changes in patients mood and cognitive function according to the neuropsychological assessment
研究概览
简要总结
Primary tumor glioblastoma is the most common malignant brain. Standard treatment includes biopsy or excision of the tumor in order to obtain a pathological diagnosis, and tumor mass reduction. After the surgery patients are treated with radiation and Temodal. The most common psychiatric symptom in this patient population is depression, valued at up to approximately 50% in patients with glioma . Depression not only adversely affects the quality of life of patients but also impairs the ability and cognitive function due to the complex clinical course of patients with glioblastoma. There is a tendency to give Diagnosis of depression in this patient population, due to a lack of awareness, knowledge and literature on the subject. This study was designed to prospectively randomized, controlled, double-blind study.
This method of recruitment - patients who undergo resection or biopsy of glioblastoma (newly diagnosed glioblastoma), immediately after diagnosis, patients will receive an explanation about the study and sign a consent form will enter research.
详细描述
This study was designed to prospectively randomized, controlled, double-blind study.This method of recruitment patients who undergo resection or biopsy of glioblastoma (newly diagnosed glioblastoma), immediately after diagnosis, patients will receive an explanation about the study and sign a consent form will enter research.
Patients who underwent resection or biopsy of glioblastoma (newly diagnosed glioblastoma), will randomization ratio of 1: 1 by the pharmacist (by age, Karnofsky score, the degree of tumor resection) two research groups:
Group # 1: consisting of 50 patients who will be treated immediately after diagnosis, 30 mg Cymbalta morning for a week and then a dose exceeding 60 mg for 3 months.
Group # 2: will include 50 patients treated immediately after diagnosis placebo for 3 months.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who signed an informed consent form
- •Patients who underwent resection or biopsy for GBM
排除标准
- •Patients being treated with antidepressants
- •Unable to answer the questionnaires because of an inability to communicate
- •Patients being treated; monoamine oxidase inhibitors (MAOI) CYP1A2 Inhibitors or (CYP2D6 inhibitors (SSRIs such as fluoxetine, paroxetine, or anti-arrhythmia such as quinidine) Patients with Glaucoma, narrow angle
- •Severe renal dysfunction. According to laboratory criteria specified earlier.
- •Hepatic insufficiency - which laboratory criteria mentioned earlier.
- •Pregnant women Patients Dementia
- •Patients who previously suffered from depression in the past or within 5 years of diagnosis, and currently do not receive drug therapy
- •Sensitivity to any of its ingredients
研究组 & 干预措施
Group # 1- ACTIVE
Patients who underwent resection or biopsy of glioblastoma (newly diagnosed glioblastoma), will randomization ratio of 1: 1 by the pharmacist (by age, KPS, the degree of tumor resection) two research groups:
Group # 1: consisting of 50 patients who will be treated immediately after diagnosis, 30 mg Cymbalta duloxetine -morning for a week and then a dose exceeding 60 mg for 3 months.
干预措施: duloxetine (Drug)
Group # 2-PLACEBO
Group # 2 will include 50 patients treated immediately after diagnosis with placebo for 3 months
干预措施: PLACEBO (Drug)
结局指标
主要结局
changes in patients mood and cognitive function according to the neuropsychological assessment
时间窗: 3 months of treatment
次要结局
未报告次要终点
研究者
michal roll
Director R & D
Tel-Aviv Sourasky Medical Center