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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02443194
• Other study ID #: 0124-15 TLV
• Status: Terminated
• Phase: Phase 3
• First received: May 3, 2015
• Last updated: December 2, 2015
• Start date: May 2015
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Glioblastoma

Intervention

Drug:
• duloxetine
after randomization the patient will receive cymbalta/ placebo for 3 months
• PLACEBO
after randomization the patient will receive cymbalta/ placebo for 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
michal roll

References & Publications (1)

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 i

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in patients mood and cognitive function according to the neuropsychological assessment		3 months of treatment	No