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CompletedNCT02246244TADDORUpdated Jun 10, 2016

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

A Phase 3 interventional study of Escitalopram and Placebo in ENT Cancer, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-06-10.

Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • ENT Cancer
03

In context

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 242 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Escitalopram

    10 mg once per day

    Drug: Escitalopram

  • Placebo comparator
    Placebo

    Other: Placebo

Interventions

  • DrugEscitalopram
  • OtherPlacebo
06

What researchers measure

Primary outcomes

  1. Efficacy of treatment by Escitalopram on depressive symptoms

    Assessed using HADS scale

    Time frame: Assessed 3 months after randomization

Secondary outcomes

  1. Efficacy of treatment on emotional distress

    Assessed using HADS scale

    Time frame: Assessed 3 months after randomization

07

Study locations

1 site
  • Gustave Roussy
    Villejuif, Val de Marne 94805, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02246244
Lead sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Responsible party
Sponsor
First posted
Sep 22, 2014
Start date
Apr 2009
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Jun 10, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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