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

Depression Clinical Trial

— Cipralex&GBM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02623231
• Other study ID #: 0600-15
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: November 10, 2015
• Last updated: December 2, 2015
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: December 2015
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Rachel Grossman, MD
• Phone: 972-3-6972731
• Email: rachelg[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Depression
• GBM
• Glioblastoma

Intervention

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
• 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

Locations

Country	Name	City	State
Israel	The Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in patients mood and cognitive function according to the neuropsychological assessment that includes patient health questionnaire (PHQ9)		3 months	No