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Trial record 47 of 513 for:    ESCITALOPRAM AND Serotonin Uptake

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

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ClinicalTrials.gov Identifier: NCT02623231
Recruitment Status : Unknown
Verified December 2015 by michal roll, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 7, 2015
Last Update Posted : December 7, 2015
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

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

Condition or disease Intervention/treatment Phase
GBM Depression Drug: Escitalopram Drug: placebo Phase 2 Phase 3

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of Escitalopram on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients
Study Start Date : December 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: escitalopram
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
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
Other Name: Cipralex

Drug: placebo
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

Placebo Comparator: placebo
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
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
Other Name: Cipralex

Drug: placebo
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 Measures :
  1. changes in patients mood and cognitive function according to the neuropsychological assessment that includes patient health questionnaire (PHQ9) [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623231


Contacts
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Contact: Rachel Grossman, MD 972-3-6972731 rachelg@tlvmc.gov.il
Contact: Carmit Ben Harosh, RN 6974397 Carmitbh@tlvmc.gov.il

Locations
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Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Rachel Grossman, MD tasmc,

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Responsible Party: michal roll, Director of R & D department, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02623231     History of Changes
Other Study ID Numbers: 0600-15
First Posted: December 7, 2015    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
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Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents