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

Study Overview
=================
Brief Summary
-----------------
Primary tumor glioblastoma is the most common malignant brain. Standard treatment includes biopsy or excision of the tumor in order to obtain a pathological diagnosis, and tumor mass reduction. After the surgery patients are treated with radiation and Temodal. The most common psychiatric symptom in this patient population is depression, valued at up to approximately 50% in patients with glioma . Depression not only adversely affects the quality of life of patients but also impairs the ability and cognitive function due to the complex clinical course of patients with glioblastoma. There is a tendency to give Diagnosis of depression in this patient population, due to a lack of awareness, knowledge and literature on the subject. This study was designed to prospectively randomized, controlled, double-blind study. This method of recruitment - patients who undergo resection or biopsy of glioblastoma (newly diagnosed glioblastoma), immediately after diagnosis, patients will receive an explanation about the study and sign a consent form will enter research.

Detailed Description
-----------------
This study was designed to prospectively randomized, controlled, double-blind study.This method of recruitment patients who undergo resection or biopsy of glioblastoma (newly diagnosed glioblastoma), immediately after diagnosis, patients will receive an explanation about the study and sign a consent form will enter research. Patients who underwent resection or biopsy of glioblastoma (newly diagnosed glioblastoma), will randomization ratio of 1: 1 by the pharmacist (by age, Karnofsky score, the degree of tumor resection) two research groups: Group # 1: consisting of 50 patients who will be treated immediately after diagnosis, 30 mg Cymbalta morning for a week and then a dose exceeding 60 mg for 3 months. Group # 2: will include 50 patients treated immediately after diagnosis placebo for 3 months.

Official Title
-----------------
The Effect of Duloxetine on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: duloxetine
* Drug: PLACEBO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who signed an informed consent form Patients who underwent resection or biopsy for GBM KPS> 70 Exclusion Criteria: Patients being treated with antidepressants Unable to answer the questionnaires because of an inability to communicate Patients being treated; monoamine oxidase inhibitors (MAOI) CYP1A2 Inhibitors or (CYP2D6 inhibitors (SSRIs such as fluoxetine, paroxetine, or anti-arrhythmia such as quinidine) Patients with Glaucoma, narrow angle Severe renal dysfunction. According to laboratory criteria specified earlier. Hepatic insufficiency - which laboratory criteria mentioned earlier. Pregnant women Patients Dementia Patients who previously suffered from depression in the past or within 5 years of diagnosis, and currently do not receive drug therapy Sensitivity to any of its ingredients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group # 1- ACTIVE<br>Patients who underwent resection or biopsy of glioblastoma (newly diagnosed glioblastoma), will randomization ratio of 1: 1 by the pharmacist (by age, KPS, the degree of tumor resection) two research groups: Group # 1: consisting of 50 patients who will be treated immediately after diagnosis, 30 mg Cymbalta duloxetine -morning for a week and then a dose exceeding 60 mg for 3 months. | Drug: duloxetine<br>* after randomization the patient will receive cymbalta/ placebo for 3 months<br>* Other names: cymbalta;|
| Placebo Comparator: Group # 2-PLACEBO<br>Group # 2 will include 50 patients treated immediately after diagnosis with placebo for 3 months | Drug: PLACEBO<br>* after randomization the patient will receive cymbalta/ placebo for 3 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in patients mood and cognitive function according to the neuropsychological assessment |  | 3 months of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, glioblastoma