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Completed

NCT Number: NCT02246244

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

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.

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Key information

Conditions

ENT Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gustave Roussy

Villejuif, Val de Marne, 94805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Escitalopram

Drug

Placebo

Other

Primary outcomes

  1. Efficacy of treatment by Escitalopram on depressive symptoms

    Time frame: Assessed 3 months after randomization

    Assessed using HADS scale

Secondary outcomes

  1. Efficacy of treatment on emotional distress

    Time frame: Assessed 3 months after randomization

    Assessed using HADS scale

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study title

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

Acronym: TADDOR

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Sep 22, 2014
Registry last updated
Jun 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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