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

NCT ID: NCT02246244

Last Updated: 2016-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2013-03-31

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.

Conditions

ENT Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Escitalopram

10 mg once per day

Group Type: EXPERIMENTAL

Escitalopram

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Escitalopram

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gustave Roussy

Villejuif, Val de Marne, France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 36999619 (View on PubMed)

Other Identifiers

2008/1388

Identifier Type: OTHER

Identifier Source: secondary_id

2008-002159-25

Identifier Type: -

Identifier Source: org_study_id