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

NCT02623231 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-12-07

No results posted yet for this study

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

Conditions

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

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Rachel Grossman, MD · tasmc,

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Israel

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02623231 on ClinicalTrials.gov