The Effect of Duloxetine on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients
Primary Purpose
Depression
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
duloxetine
PLACEBO
Sponsored by
About this trial
This is an interventional prevention trial for Depression focused on measuring depression, glioblastoma
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group # 1- ACTIVE
Group # 2-PLACEBO
Arm Description
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.
Group # 2 will include 50 patients treated immediately after diagnosis with placebo for 3 months
Outcomes
Primary Outcome Measures
changes in patients mood and cognitive function according to the neuropsychological assessment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02443194
Brief Title
The Effect of Duloxetine on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients
Official Title
The Effect of Duloxetine on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
principle investigator decision due to many adverse events in patients
Study Start Date
May 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
michal roll
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, glioblastoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group # 1- ACTIVE
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group # 2-PLACEBO
Arm Type
Placebo Comparator
Arm Description
Group # 2 will include 50 patients treated immediately after diagnosis with placebo for 3 months
Intervention Type
Drug
Intervention Name(s)
duloxetine
Other Intervention Name(s)
cymbalta
Intervention Description
after randomization the patient will receive cymbalta/ placebo for 3 months
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Intervention Description
after randomization the patient will receive cymbalta/ placebo for 3 months
Primary Outcome Measure Information:
Title
changes in patients mood and cognitive function according to the neuropsychological assessment
Time Frame
3 months of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Grossman, MD
Organizational Affiliation
Neurosurgery department, Tel Aviv Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
24563781
Citation
Greer TL, Sunderajan P, Grannemann BD, Kurian BT, Trivedi MH. Does duloxetine improve cognitive function independently of its antidepressant effect in patients with major depressive disorder and subjective reports of cognitive dysfunction? Depress Res Treat. 2014;2014:627863. doi: 10.1155/2014/627863. Epub 2014 Jan 19.
Results Reference
result
Learn more about this trial
The Effect of Duloxetine on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients
We'll reach out to this number within 24 hrs