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

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Depression; GBM

Treatments: Drug: Escitalopram; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02623231

0600-15

Details and patient eligibility

About

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

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

escitalopram

Experimental group

Description:

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

Treatment:

Drug: placebo

Drug: Escitalopram

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo

Drug: Escitalopram