Depression, GBM
Conditions
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).
Interventions
DRUGEscitalopram
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
DRUGplacebo
group # 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
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
\* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in patients mood and cognitive function according to the neuropsychological assessment that includes patient health questionnaire (PHQ9) | 3 months |
Countries
Israel
Contacts
Primary ContactRachel Grossman, MD
Backup ContactCarmit Ben Harosh, RN
Outcome results
None listed