Randomized, Double Blind, Efficacy Study of Escitalopram... | NCT02246244

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

NCT02246244

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Completed

Last Update Posted

Jun 10, 2016Estimated

Enrollment

38Actual

Phase

Phase 3

Conditions

ENT Cancer

Interventions

Escitalopram
Placebo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008/1388	Other Identifier	CSET number

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Sep 17, 2014

First Submission Date that Met QC Criteria

Sep 18, 2014

First Posted Date

Sep 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2016

Last Update Posted Date

Jun 10, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Label	Type	Description	Intervention Names
Escitalopram	Experimental	10 mg once per day	Drug: Escitalopram
Placebo	Placebo Comparator		Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Escitalopram	Drug		Escitalopram
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy of treatment by Escitalopram on depressive symptoms	Assessed using HADS scale	Assessed 3 months after randomization

Secondary Outcomes

Measure	Description	Time Frame
Efficacy of treatment on emotional distress	Assessed using HADS scale	Assessed 3 months after randomization

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Gustave Roussy		Villejuif	Val de Marne	94805	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36999619	Derived	Vita G, Compri B, Matcham F, Barbui C, Ostuzzi G. Antidepressants for the treatment of depression in people with cancer. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD011006. doi: 10.1002/14651858.CD011006.pub4.

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572