Clinical trial NCT02246244: Randomized, Double Blind, Efficacy Study of Escitalopram in ENT Cancer Patients Suffering From Emotional Distress
Official title: Randomized, Double Blind, Efficacy Study of Escitalopram Versus Placebo in ENT Cancer Patients Suffering From Emotional Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ENT Cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of treatment by Escitalopram on depressive symptoms
timeFrame: Assessed 3 months after randomization
Secondary outcomes:
measure: Efficacy of treatment on emotional distress
timeFrame: Assessed 3 months after randomization
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val de Marne
Study officials:
References: