Overview
The Effect of Escitalopram on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients
Status:
Unknown status
Unknown status
Trial end date:
2017-12-01
2017-12-01
Target enrollment:
0
0
Participant gender:
All
All
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 NeurotraxPhase:
Phase 2/Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Tel-Aviv Sourasky Medical CenterTreatments:
Citalopram
Dexetimide
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