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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Double Blind, Efficacy Study of Escitalopram Versus Placebo in ENT Cancer Patients Suffering From Emotional Distress

Conditions
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ENT Cancer

Intervention / Treatment
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* Drug: Escitalopram
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escitalopram<br>10 mg once per day | Drug: Escitalopram<br> <br> |
| Placebo Comparator: Placebo<br> | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment by Escitalopram on depressive symptoms | Assessed using HADS scale | Assessed 3 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment on emotional distress | Assessed using HADS scale | Assessed 3 months after randomization |