cropped color_logo_with_background.png

Clinical Trial Finder

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02623231
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Tel-Aviv Sourasky Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Rachel Grossman, MD
Principal Investigator Affiliation tasmc,
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Unknown status
Countries Israel
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 GBM, Depression
Additional Details

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).

Arms & Interventions

Arms

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

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

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

The Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Status

Address

The Tel Aviv Sourasky Medical Center

Tel Aviv, ,

Powered By