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

NCT02443194 | Terminated Phase 3

• 1 other identifier: 0124-15 TLV
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression

Keywords

depression; glioblastoma

Outcome Measures

Primary Outcomes (1)

• changes in patients mood and cognitive function according to the neuropsychological assessment

  3 months of treatment

Study Arms (2)

Group # 1- ACTIVE

ACTIVE COMPARATOR

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

Group # 2-PLACEBO

PLACEBO COMPARATOR

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

Drug: PLACEBO

Interventions

duloxetine DRUG

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

Also known as: cymbalta

Group # 1- ACTIVE

PLACEBO DRUG

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

Group # 2-PLACEBO

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who signed an informed consent form
• Patients who underwent resection or biopsy for GBM
• KPS\> 70

You may not qualify if:

• 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

Sponsors & Collaborators

• michal roll: lead

Related Publications (1)

• 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.

  PMID: 24563781 RESULT

MeSH Terms

Conditions

Depression; Glioblastoma

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rachel Grossman, MD

  Neurosurgery department, Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director R & D

Study Record Dates

• First Submitted: May 3, 2015
• First Posted: May 13, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12