NCT02623231

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• GBM
• Depression

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-12-07
• Last updated: 2015-12-07

Locations

1 site across 1 country: Israel