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The Effect of Escitalopram on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients (Cipralex&GBM)

Primary Purpose

GBM, Depression

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Escitalopram

placebo

About this trial

This is an interventional supportive care trial for GBM

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:* men and women

Aged 18-80
who signed an informed consent form
patients that underwent biopsy or resection of brain glioblastoma.
KPS≥70
Patients that are stable in terms of seizures who take only one antiepileptic drug

Exclusion Criteria:

Patients who suffered from depression within five years,
Patients treated with antidepressants
Are not able to answer the questionnaires because of an inability to communicate
Patients treated with inhibitors (MAOI) such as: nialamide , isocarboxazid , iproniazid, phenerzine, tranylcypromine
Patients who suffer from epilepsy.
Patients who suffer from Parkinson's
Patients who suffer from cardiac dysfunction or heart attack recently.
Patients with eye problems in expanding pupils - can result in the development of glaucoma and closed angle.
Severe renal dysfunction. (creatinine clearance <30 mL / min). , Creatinine less than 1.5 times the upper limit of normal or end-stage renal disease
Hepatic insufficiency -bilirubin General> 1.5 times the upper limit of normal, Hepatic Enzymes less than 2.5 times upper limit of normal
Pregnant women
a score of less than 24 test The mini-mental state examination (MMSE)
allergy to any component of the drug- Talc, croscarmellose sodium, Microcrystalline Cellulose silicified, Magnesium stearate, Hypromellose, Macrogol 400, Titanium Dioxide

Sites / Locations

The Tel Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

escitalopram

placebo

Arm Description

Group number 1 will include 50 patients, who will receive Escitalopram at a dose of 10 mg for a week exceeding 20 mg immediately after diagnosis for 3 months

Group number 2 will include 50 patients, who will receive Placebo at a dose of 10 mg for a week exceeding 20 mg immediately after diagnosis for 3 months

Outcomes

Primary Outcome Measures

changes in patients mood and cognitive function according to the neuropsychological assessment that includes patient health questionnaire (PHQ9)

Secondary Outcome Measures

Full Information

NCT ID

NCT02623231

First Posted

November 10, 2015

Last Updated

December 2, 2015

Sponsor

Tel-Aviv Sourasky Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02623231

Brief Title

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

Acronym

Cipralex&GBM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Testing the effect of providing an antidepressant and anxiety-type escitalopram for patients with glioblastoma on patient's quality of life including the effect of treatment on mood and cognition during treatment.Two subgroups will fill questionnaires : Questionnaire mini mental state exam (mmse) which is the maximum score of 30. A score of below 24 indicates a flaw in the level of dementia Questionnaire depression / mood PHQ9P(Pa t i e n t H e a l t h Qu e s t i o n n a i r e - 9) The M. D. Anderson Symptom Inventory (MDASI) Evaluation of the hospital situation awareness (clinical assessment and questionnaire) Cognitive assessment which will be carried out by the Department neuropsychological and include: Executive function (Stroop) Abstract Reasoning (similarities) -Auditory and Spatial Attention (Digit span, Spatial span) visual memory and remembering Literature Memory function - visual and auditory (ROCF, RAVLT) Language function: Naming and verbal fluency Mindstreems Neurotrax

Detailed Description

This study is planned as prospective randomized, controlled, double-blind study. Patients will undergo resection or biopsy of glioblastoma (newly diagnosed glioblastoma), will randomization ratio of 1: 1 by the pharmacist (by age,Karnofsky score, extent of tumor resection), for two research groups: Group number 1 will include 50 patients, who will receive Escitalopram or Placebo at a dose of 10 mg for a week exceeding 20 mg immediately after diagnosis for 3 months. . The dose study is fixed and is not aimed at symptomatic treatment of anti-depressant (such as major depression).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

GBM, Depression

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

escitalopram

Arm Type

Experimental

Arm Description

Group number 1 will include 50 patients, who will receive Escitalopram at a dose of 10 mg for a week exceeding 20 mg immediately after diagnosis for 3 months

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Group number 2 will include 50 patients, who will receive Placebo at a dose of 10 mg for a week exceeding 20 mg immediately after diagnosis for 3 months

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Other Intervention Name(s)

Cipralex

Intervention Description

Group number 1 will include 50 patients, who will receive Escitalopram at a dose of 10 mg for a week exceeding 20 mg immediately after diagnosis for 3 months

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

group # 2 Will include 50 patients , who will receive placebo at a dose of 10 mg for a week exceeding 20 mg immediately after diagnosis for 3 months

Primary Outcome Measure Information:

Title

changes in patients mood and cognitive function according to the neuropsychological assessment that includes patient health questionnaire (PHQ9)

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria:* men and women Aged 18-80 who signed an informed consent form patients that underwent biopsy or resection of brain glioblastoma. KPS≥70 Patients that are stable in terms of seizures who take only one antiepileptic drug Exclusion Criteria: Patients who suffered from depression within five years, Patients treated with antidepressants Are not able to answer the questionnaires because of an inability to communicate Patients treated with inhibitors (MAOI) such as: nialamide , isocarboxazid , iproniazid, phenerzine, tranylcypromine Patients who suffer from epilepsy. Patients who suffer from Parkinson's Patients who suffer from cardiac dysfunction or heart attack recently. Patients with eye problems in expanding pupils - can result in the development of glaucoma and closed angle. Severe renal dysfunction. (creatinine clearance <30 mL / min). , Creatinine less than 1.5 times the upper limit of normal or end-stage renal disease Hepatic insufficiency -bilirubin General> 1.5 times the upper limit of normal, Hepatic Enzymes less than 2.5 times upper limit of normal Pregnant women a score of less than 24 test The mini-mental state examination (MMSE) allergy to any component of the drug- Talc, croscarmellose sodium, Microcrystalline Cellulose silicified, Magnesium stearate, Hypromellose, Macrogol 400, Titanium Dioxide

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rachel Grossman, MD

Phone

972-3-6972731

rachelg@tlvmc.gov.il

First Name & Middle Initial & Last Name or Official Title & Degree

Carmit Ben Harosh, RN

Phone

6974397

Carmitbh@tlvmc.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rachel Grossman, MD

Organizational Affiliation

tasmc,

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Tel Aviv Sourasky Medical Center

City

Tel Aviv

Country

Israel

12. IPD Sharing Statement

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

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