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Trial record 21 of 489 for:    ESCITALOPRAM AND Antagonists

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

Tracking Information
First Submitted Date  ICMJE November 10, 2015
First Posted Date  ICMJE December 7, 2015
Last Update Posted Date December 7, 2015
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2015)
changes in patients mood and cognitive function according to the neuropsychological assessment that includes patient health questionnaire (PHQ9) [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Escitalopram on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients
Official Title  ICMJE The Effect of Escitalopram on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • GBM
  • Depression
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Escitalopram
    • Drug: placebo
  • 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
    Interventions:
    • Drug: Escitalopram
    • Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 2, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02623231
Other Study ID Numbers  ICMJE 0600-15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party michal roll, Tel-Aviv Sourasky Medical Center
Study Sponsor  ICMJE Tel-Aviv Sourasky Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rachel Grossman, MD tasmc,
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP