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

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ClinicalTrials.gov Identifier: NCT02443194
Recruitment Status : Terminated (principle investigator decision due to many adverse events in patients)
First Posted : May 13, 2015
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

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.


Condition or disease Intervention/treatment Phase
Depression Drug: duloxetine Drug: PLACEBO Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Duloxetine on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients
Study Start Date : May 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015


Arm Intervention/treatment
Active Comparator: Group # 1- ACTIVE

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
after randomization the patient will receive cymbalta/ placebo for 3 months
Other Name: cymbalta

Placebo Comparator: Group # 2-PLACEBO
Group # 2 will include 50 patients treated immediately after diagnosis with placebo for 3 months
Drug: PLACEBO
after randomization the patient will receive cymbalta/ placebo for 3 months




Primary Outcome Measures :
  1. changes in patients mood and cognitive function according to the neuropsychological assessment [ Time Frame: 3 months of treatment ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443194


Sponsors and Collaborators
michal roll
Investigators
Principal Investigator: Rachel Grossman, MD Neurosurgery department, Tel Aviv Medical Center

Publications of Results:
2. Rooney AG, Carson A, Grant R (2011) Depression in cerebral glioma patients: a systematic review of observational studies. J Natl Cancer Inst 103(1):61-76 3. Wellisch DK, Kaleita TA, Freeman D, Cloughesy T, Goldman J (2002) Predicting major depression in brain tumor patients. Psycho-Oncology 11:230-238 4. Mainio A et al (2005) Depression and functional outcome in patients with brain tumors: a population-based 1-year follow-up study. J Neurosurg 103(5):841-847. 10. Does duloxetine improve cognitive function independently of its antidepressant effect in patients with major depressive disorder and subjective reports of cognitive dysfunction? Greer TL, Sunderajan P, Grannemann BD, Kurian BT, Trivedi MH. Depress Res Treat. 2014;2014:627863.

Responsible Party: michal roll, Director R & D, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02443194     History of Changes
Other Study ID Numbers: 0124-15 TLV
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by michal roll, Tel-Aviv Sourasky Medical Center:
depression
glioblastoma

Additional relevant MeSH terms:
Depression
Glioblastoma
Behavioral Symptoms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents