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

Randomized, Double Blind, Efficacy Study of Escitalopram Versus Placebo 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.

Study Overview

• Status: Completed
• Conditions: ENT Cancer
• Intervention / Treatment: Other: Placebo; Drug: Escitalopram

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Val de Marne
    • Villejuif, Val de Marne, France, 94805
      • Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo
Experimental: Escitalopram; 10 mg once per day	Drug: Escitalopram

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: September 17, 2014
• First Submitted That Met QC Criteria: September 18, 2014
• First Posted (Estimate): September 22, 2014

Study Record Updates

• Last Update Posted (Estimate): June 10, 2016
• Last Update Submitted That Met QC Criteria: June 9, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: 2008-002159-25; 2008/1388 (Other Identifier: CSET number)