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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
michal roll
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring depression, glioblastoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 3, 2015
    Last Updated
    December 2, 2015
    Sponsor
    michal roll
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    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

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

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