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

Phase 3

Completed

• Conditions: ENT Cancer
• Interventions: Drug: Escitalopram; Other: Placebo

• Registration Number: NCT02246244
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-22
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-09
• Last Update Posted: 2016-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Escitalopram	Escitalopram	10 mg once per day
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Efficacy of treatment by Escitalopram on depressive symptoms	Assessed 3 months after randomization	Assessed using HADS scale

Secondary Outcome Measures

Name	Time	Method
Efficacy of treatment on emotional distress	Assessed 3 months after randomization	Assessed using HADS scale

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, Val de Marne, France