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

NCT ID: NCT02623231

Last Updated: 2015-12-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-12-31

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).

Conditions

GBM; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Escitalopram

Intervention Type: DRUG

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

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Escitalopram

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Cipralex

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

michal roll

Director of R & D department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel Grossman, MD

Role: PRINCIPAL_INVESTIGATOR

tasmc,

Locations

The Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Countries

Israel

Central Contacts

Rachel Grossman, MD

Role: CONTACT

rachelg@tlvmc.gov.il

972-3-6972731

Carmit Ben Harosh, RN

Role: CONTACT

Carmitbh@tlvmc.gov.il

6974397

Other Identifiers

0600-15

Identifier Type: -

Identifier Source: org_study_id