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Trial record 82 of 585 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

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.


Condition or disease Intervention/treatment Phase
ENT Cancer Drug: Escitalopram Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Escitalopram
10 mg once per day
Drug: Escitalopram
Placebo Comparator: Placebo Other: Placebo



Primary Outcome Measures :
  1. Efficacy of treatment by Escitalopram on depressive symptoms [ Time Frame: Assessed 3 months after randomization ]
    Assessed using HADS scale


Secondary Outcome Measures :
  1. Efficacy of treatment on emotional distress [ Time Frame: Assessed 3 months after randomization ]
    Assessed using HADS scale



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246244


Locations
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France
Gustave Roussy
Villejuif, Val de Marne, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris

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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT02246244     History of Changes
Other Study ID Numbers: 2008-002159-25
2008/1388 ( Other Identifier: CSET number )
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
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Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents