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

NCT02623231 | Unknown Phase 2

• 1 other identifier: 0600-15
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

GBM; Depression

Outcome Measures

Primary Outcomes (1)

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

  3 months

Study Arms (2)

escitalopram

EXPERIMENTAL

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

Drug: Escitalopram; Drug: placebo

placebo

PLACEBO COMPARATOR

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

Drug: Escitalopram; Drug: placebo

Interventions

Escitalopram DRUG

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

Also known as: Cipralex

escitalopram; placebo

placebo DRUG

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

escitalopram; 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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

The Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Depression

Interventions

Escitalopram; Dexetimide

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Rachel Grossman, MD

  tasmc,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Grossman, MD

CONTACT

972-3-6972731; rachelg@tlvmc.gov.il

Carmit Ben Harosh, RN

CONTACT

6974397; Carmitbh@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of R & D department

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: December 7, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 7, 2015

Record last verified: 2015-12

Locations

IL (1)