The Effect of Escitalopram on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients
- Registration Number
- NCT02623231
- Lead Sponsor
- Tel-Aviv Sourasky Medical Center
- Brief Summary
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 :
* 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
* 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)
* The M. D. Anderson Symptom Inventory (MDASI)
* Evaluation of the hospital situation awareness (clinical assessment and questionnaire)
* Cognitive assessment which will be carried out by the Department neuropsychological and include:
* Executive function (Stroop)
* Abstract Reasoning (similarities)
* -Auditory and Spatial Attention (Digit span, Spatial span) visual memory and remembering Literature
* Memory function - visual and auditory (ROCF, RAVLT)
* Language function: Naming and verbal fluency
* Mindstreems Neurotrax
- Detailed Description
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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
* men and women
- Aged 18-80
- who signed an informed consent form
- patients that underwent biopsy or resection of brain glioblastoma.
- KPS≥70
- Patients that are stable in terms of seizures who take only one antiepileptic drug
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description escitalopram placebo 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 placebo 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 escitalopram 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 placebo Escitalopram 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
- Primary Outcome Measures
Name Time Method changes in patients mood and cognitive function according to the neuropsychological assessment that includes patient health questionnaire (PHQ9) 3 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel