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Trial record 85 of 592 for:    ESCITALOPRAM AND Celexa

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

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ClinicalTrials.gov Identifier: NCT02246244
Recruitment Status : Completed
First Posted : September 22, 2014
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Tracking Information
First Submitted Date  ICMJE September 17, 2014
First Posted Date  ICMJE September 22, 2014
Last Update Posted Date June 10, 2016
Study Start Date  ICMJE April 2009
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2014)
Efficacy of treatment by Escitalopram on depressive symptoms [ Time Frame: Assessed 3 months after randomization ]
Assessed using HADS scale
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02246244 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2014)
Efficacy of treatment on emotional distress [ Time Frame: Assessed 3 months after randomization ]
Assessed using HADS scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized, Double Blind, Efficacy Study of Escitalopram in ENT Cancer Patients Suffering From Emotional Distress
Official Title  ICMJE Randomized, Double Blind, Efficacy Study of Escitalopram Versus Placebo in ENT Cancer Patients Suffering From Emotional Distress
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE ENT Cancer
Intervention  ICMJE
  • Drug: Escitalopram
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: Escitalopram
    10 mg once per day
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2016)
38
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2014)
100
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02246244
Other Study ID Numbers  ICMJE 2008-002159-25
2008/1388 ( Other Identifier: CSET number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gustave Roussy, Cancer Campus, Grand Paris
Study Sponsor  ICMJE Gustave Roussy, Cancer Campus, Grand Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Gustave Roussy, Cancer Campus, Grand Paris
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP