Status:
COMPLETED
Randomized, Double Blind, Efficacy Study of Escitalopram in ENT Cancer Patients Suffering From Emotional Distress
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
ENT Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Escitalopram is an antidepressant inhibitor of the serotonin reuptake. On the market in France since 2002. Prevalence of emotional distress in patients with cancer is 30-50%. this prevalence may vary...
Eligibility Criteria
Inclusion
- Patients with ENT cancer of stage I to IVb that have to go under surgery and/or radiotherapy and/or chemotherapy as first line treatment. It may be a primary cancer or a new localisation.
- Total score on HADS scale \>11
- Patients aged from 18 to 75 years
- Signed informed consent
- OMS \< 2, hospitalized or ambulatory
- Are authorized to inclusion, psychoactive treatments at stable dosage for two weeks for benzodiazepins, neuroleptics, antihistaminics or other anxiolytics or hypnotics
Exclusion
- Patients in palliative treatments
- Previous bipolar disorder or schizophrenia
- Major depressive episode with severity criteria
- Suicidal patients
- Acute infection
- ASAT/ALAT \>3N
- Creatinine clearance \<30 ml/mn
- Natremia inferior to the laboratory standard
- For alcoholic patients non abstinent at the time of inclusion, previous "delirium tremens"
- Previous upper gist bleeding
- Inefficacy or intolerance of previous treatment by escitalopram
- Not compatible concomitant treatment:
- Other antidepressive than escitalopram (except clonazepam)
- all hypnotics (except zolpidem)
- all anxiolytics (except clonazepam, clorazepate and diazepam)
- medical treatment for smoking addiction like bupropion or varenicline
- Pregnant or breastfeeding women
- Patients under guardianship
- Patients without insurance
- Impossibility to follow the protocol for geographical, social or psychic reasons
- Insufficient knowledge of French
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT02246244
Start Date
April 1 2009
End Date
March 1 2013
Last Update
June 10 2016
Active Locations (1)
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1
Gustave Roussy
Villejuif, Val de Marne, France, 94805