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

NCT02246244 | Completed Phase 3

• 2 other identifiers: 2008-002159-252008/1388
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Efficacy of treatment by Escitalopram on depressive symptoms

  Assessed using HADS scale

  Assessed 3 months after randomization

Secondary Outcomes (1)

• Efficacy of treatment on emotional distress

  Assessed 3 months after randomization

Study Arms (2)

Escitalopram

EXPERIMENTAL

10 mg once per day

Drug: Escitalopram

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Escitalopram DRUG

Escitalopram

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, Val de Marne, 94805, France

Location

Related Publications (1)

• 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.

  PMID: 36999619 DERIVED

MeSH Terms

Interventions

Escitalopram

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: September 22, 2014
• Study Start: April 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 10, 2016

Record last verified: 2016-06

Locations

FR (1)