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

NCT ID: NCT02443194

Last Updated: 2015-12-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-11-30

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

duloxetine

Intervention Type: DRUG

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

Group # 2-PLACEBO

Group # 2 will include 50 patients treated immediately after diagnosis with placebo for 3 months

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DRUG

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

Interventions

duloxetine

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

Intervention Type: DRUG

PLACEBO

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

Intervention Type: DRUG

Other Intervention Names

cymbalta

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

michal roll

OTHER_GOV

Sponsor Role: lead

Responsible Party

michal roll

Director R & D

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rachel Grossman, MD

Role: PRINCIPAL_INVESTIGATOR

Neurosurgery department, Tel Aviv Medical Center

References

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.

Reference Type: RESULT

PMID: 24563781 (View on PubMed)

Other Identifiers

0124-15 TLV

Identifier Type: -

Identifier Source: org_study_id