Randomized, Double Blind, Efficacy Study of Escitalopram in ENT Cancer Patients Suffering From Emotional Distress (TADDOR)

Gustave Roussy

Status and phase

Completed

Phase 3

Conditions

ENT Cancer

Treatments

Other: Placebo

Drug: Escitalopram

Study type

Interventional

Funder types

Other

Identifiers

NCT02246244

2008/1388 (Other Identifier)

2008-002159-25

Details and patient eligibility

About

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 regarding the tumor localisation, the population, intensity of the symptoms...

Incidence of ENT cancer is highly significant in France, it is one of the most important in the world 37 out of 100 000. it is in patients with ENT cancer that the prevalence of depression is the most important (22%-57%).

Researches appears necessary to assessed the efficacy of antidepressant treatments with as primary objective not only the decrease of depressive symptoms but also an ensemble of physic and psychological symptoms.

Enrollment

38 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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