GBMPhase 2/3Cipralex&GBMNCT02623231
The Effect of Escitalopram on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients
A Phase 2/3 study testing Escitalopram in people with GBM and Depression, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- GBM, Depression
- What is being tested?
- Escitalopram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2015to Dec 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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).
- Conditions
- GBM, Depression
- Being tested
- Escitalopram, placebo
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Cipralex
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
placeboDrug
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Escitalopram; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in patients mood and cognitive function according to the neuropsychological assessment that includes patient health questionnaire (PHQ9)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GBMStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
- Investigators
- Rachel Grossman, MD, Principal investigator, tasmc,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623231
- Sponsor's protocol ID
- 0600-15
- Acronym
- Cipralex&GBM
- Status last verified
- Dec 2015
- First submitted
- 10 Nov 2015
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Escitalopram on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients
- ClinicalTrials.gov ID
- NCT02623231
- Acronym / sponsor ID
- Cipralex&GBM / 0600-15
- Conditions
- GBM, Depression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Dec 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 7 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| escitalopram | Experimental | Drug: Escitalopram, Drug: placeboGroup 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 |
| placebo | Placebo comparator | Drug: Escitalopram, Drug: placeboGroup 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscitalopramAlso: CipralexGroup 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, placebo |
| placebogroup # 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, placebo |
Primary outcome
changes in patients mood and cognitive function according to the neuropsychological assessment that includes patient health questionnaire (PHQ9)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Grossman, MD principal investigator
tasmc,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Escitalopram in people with GBM and Depression, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Grossman, MD (972-3-6972731, rachelg@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in patients mood and cognitive function according to the neuropsychological assessment that includes patient health questionnaire (PHQ9) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2015.