Randomized, Double Blind, Efficacy Study of Escitalopram in ENT Cancer Patients Suffering From Emotional Distress (TADDOR)
|ClinicalTrials.gov Identifier: NCT02246244|
Recruitment Status : Completed
First Posted : September 22, 2014
Last Update Posted : June 10, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|ENT Cancer||Drug: Escitalopram Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized, Double Blind, Efficacy Study of Escitalopram Versus Placebo in ENT Cancer Patients Suffering From Emotional Distress|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
10 mg once per day
|Placebo Comparator: Placebo||
- Efficacy of treatment by Escitalopram on depressive symptoms [ Time Frame: Assessed 3 months after randomization ]Assessed using HADS scale
- Efficacy of treatment on emotional distress [ Time Frame: Assessed 3 months after randomization ]Assessed using HADS scale
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246244
|Villejuif, Val de Marne, France, 94805|