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

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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02443194
Enrollment
50
Registered
2015-05-13
Start date
2015-05-31
Completion date
2015-11-30
Last updated
2015-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

depression, glioblastoma

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.

Interventions

DRUGduloxetine

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

DRUGPLACEBO

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

Sponsors

michal roll
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
changes in patients mood and cognitive function according to the neuropsychological assessment3 months of treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026