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

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 Overview

• Status: Unknown
• Conditions: Depression; GBM
• Intervention / Treatment: Drug: Escitalopram; Drug: placebo

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).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Rachel Grossman, MD; Phone Number: 972-3-6972731; Email: rachelg@tlvmc.gov.il
• Study Contact Backup: Name: Carmit Ben Harosh, RN; Phone Number: 6974397; Email: Carmitbh@tlvmc.gov.il

Study Locations

• Israel
  • Tel Aviv, Israel
    • The Tel Aviv Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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; Other Names: Cipralex; 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
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	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; Other Names: Cipralex; 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Rachel Grossman, MD, tasmc,

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (Estimate): December 7, 2015

Study Record Updates

• Last Update Posted (Estimate): December 7, 2015
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: 0600-15