The Effect of Escitalopram on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- changes in patients mood and cognitive function according to the neuropsychological assessment that includes patient health questionnaire (PHQ9)
研究概览
简要总结
Testing the effect of providing an antidepressant and anxiety-type escitalopram for patients with glioblastoma on patient's quality of life including the effect of treatment on mood and cognition during treatment.Two subgroups will fill questionnaires :
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Questionnaire mini mental state exam (mmse) which is the maximum score of 30. A score of below 24 indicates a flaw in the level of dementia
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Questionnaire depression / mood PHQ9P(Pa t i e n t H e a l t h Qu e s t i o n n a i r e - 9)
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The M. D. Anderson Symptom Inventory (MDASI)
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Evaluation of the hospital situation awareness (clinical assessment and questionnaire)
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Cognitive assessment which will be carried out by the Department neuropsychological and include:
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Executive function (Stroop)
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Abstract Reasoning (similarities)
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-Auditory and Spatial Attention (Digit span, Spatial span) visual memory and remembering Literature
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Memory function - visual and auditory (ROCF, RAVLT)
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Language function: Naming and verbal fluency
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Mindstreems Neurotrax
详细描述
This study is planned as prospective randomized, controlled, double-blind study.
Patients will undergo resection or biopsy of glioblastoma (newly diagnosed glioblastoma), will randomization ratio of 1: 1 by the pharmacist (by age,Karnofsky score, extent of tumor resection), for two research groups:
Group number 1 will include 50 patients, who will receive Escitalopram or Placebo at a dose of 10 mg for a week exceeding 20 mg immediately after diagnosis for 3 months. . The dose study is fixed and is not aimed at symptomatic treatment of anti-depressant (such as major depression).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •* men and women
- •Aged 18-80
- •who signed an informed consent form
- •patients that underwent biopsy or resection of brain glioblastoma.
- •Patients that are stable in terms of seizures who take only one antiepileptic drug
排除标准
- •Patients who suffered from depression within five years,
- •Patients treated with antidepressants
- •Are not able to answer the questionnaires because of an inability to communicate
- •Patients treated with inhibitors (MAOI) such as: nialamide , isocarboxazid , iproniazid, phenerzine, tranylcypromine
- •Patients who suffer from epilepsy.
- •Patients who suffer from Parkinson's
- •Patients who suffer from cardiac dysfunction or heart attack recently.
- •Patients with eye problems in expanding pupils - can result in the development of glaucoma and closed angle.
- •Severe renal dysfunction. (creatinine clearance <30 mL / min). , Creatinine less than 1.5 times the upper limit of normal or end-stage renal disease
- •Hepatic insufficiency -bilirubin General> 1.5 times the upper limit of normal, Hepatic Enzymes less than 2.5 times upper limit of normal
- •Pregnant women
- •a score of less than 24 test The mini-mental state examination (MMSE)
- •allergy to any component of the drug- Talc, croscarmellose sodium, Microcrystalline Cellulose silicified, Magnesium stearate, Hypromellose, Macrogol 400, Titanium Dioxide
研究组 & 干预措施
escitalopram
Group number 1 will include 50 patients, who will receive Escitalopram at a dose of 10 mg for a week exceeding 20 mg immediately after diagnosis for 3 months
干预措施: Escitalopram (Drug)
escitalopram
Group number 1 will include 50 patients, who will receive Escitalopram at a dose of 10 mg for a week exceeding 20 mg immediately after diagnosis for 3 months
干预措施: placebo (Drug)
placebo
Group number 2 will include 50 patients, who will receive Placebo at a dose of 10 mg for a week exceeding 20 mg immediately after diagnosis for 3 months
干预措施: Escitalopram (Drug)
placebo
Group number 2 will include 50 patients, who will receive Placebo at a dose of 10 mg for a week exceeding 20 mg immediately after diagnosis 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 that includes patient health questionnaire (PHQ9)
时间窗: 3 months
次要结局
未报告次要终点
研究者
michal roll
Director of R & D department
Tel-Aviv Sourasky Medical Center