The Effect of Escitalopram on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2017

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

  • 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
  • Drug: placebo
    • 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

Arms, Groups and Cohorts

  • Experimental: 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 Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

  • changes in patients mood and cognitive function according to the neuropsychological assessment that includes patient health questionnaire (PHQ9)
    • Time Frame: 3 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tel-Aviv Sourasky Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: michal roll, Director of R & D department – Tel-Aviv Sourasky Medical Center
  • Overall Official(s)
    • Rachel Grossman, MD, Principal Investigator, tasmc,
  • Overall Contact(s)
    • Rachel Grossman, MD, 972-3-6972731, rachelg@tlvmc.gov.il

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