The Effect of Escitalopram on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients — Cipralex&GBM  

Depression Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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

Clinical Trial 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). ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression
• GBM
• Glioblastoma

• NCT number: NCT02623231
• Study type: Interventional
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Rachel Grossman, MD
• Phone: 972-3-6972731
• Email: rachelg@tlvmc.gov.il
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: December 2015
• Completion date: December 2017