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Double-blind, Placebo-controlled, Randomized Study of the Effectiveness of Escitalopram on Emotional Distress of Head and Neck Cancer Patients During Cancer Treatment

Primary Purpose

Carcinomas

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinomas focused on measuring Patients with head and neck squamous cell carcinomas, head and neck squamous cell carcinomas

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Head and neck squamous cell carcinomas, stage I to IVb
  2. First-line curative cancer therapy : surgery and/or brachytherapy and/or chemotherapy
  3. HADS- T >11
  4. Aged 18 to 75 yo, written consent required
  5. OMS>2

Exclusion Criteria:

  1. Palliative care
  2. Previous head and neck cancer
  3. Bipolar disorder or schizophrenia
  4. Severe major depressive disorder (DSM-IV TR)
  5. Expressed suicidal ideation
  6. Severe untreated organic disorder, especially acute infectious disorder
  7. ASAT/ALAT > 3N
  8. Clearance of creatinin < 30 ml/mn
  9. Hyponatremia
  10. Antecedent of delirium tremens or acute alcohol withdrawal disorder
  11. Antecedent of upper gastro-intestinal bleeding
  12. Antecedent of toxicity or inefficacy of a previous treatment with escitalopram
  13. Unauthorized treatments :- Antidepressant or antiepileptic (clonazepam authorized)- Hypnotic except zolpidem - Anxiolytic except clonazepam, clorazepate or diazepam- bupropion or varenicline
  14. Pregnancy or lactation

Sites / Locations

  • Institut Gustave RoussyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Antidepressant treatment

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months

Secondary Outcome Measures

Full Information

First Posted
July 7, 2009
Last Updated
September 1, 2009
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00935675
Brief Title
Double-blind, Placebo-controlled, Randomized Study of the Effectiveness of Escitalopram on Emotional Distress of Head and Neck Cancer Patients During Cancer Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

5. Study Description

Brief Summary
Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months in patients with head and neck squamous cell carcinomas (oral cavity, larynx, oropharynx and hypopharynx) and with an HADS total score > 11

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinomas
Keywords
Patients with head and neck squamous cell carcinomas, head and neck squamous cell carcinomas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antidepressant treatment
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Description
Escitalopram 10 mg once a day
Primary Outcome Measure Information:
Title
Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Head and neck squamous cell carcinomas, stage I to IVb First-line curative cancer therapy : surgery and/or brachytherapy and/or chemotherapy HADS- T >11 Aged 18 to 75 yo, written consent required OMS>2 Exclusion Criteria: Palliative care Previous head and neck cancer Bipolar disorder or schizophrenia Severe major depressive disorder (DSM-IV TR) Expressed suicidal ideation Severe untreated organic disorder, especially acute infectious disorder ASAT/ALAT > 3N Clearance of creatinin < 30 ml/mn Hyponatremia Antecedent of delirium tremens or acute alcohol withdrawal disorder Antecedent of upper gastro-intestinal bleeding Antecedent of toxicity or inefficacy of a previous treatment with escitalopram Unauthorized treatments :- Antidepressant or antiepileptic (clonazepam authorized)- Hypnotic except zolpidem - Anxiolytic except clonazepam, clorazepate or diazepam- bupropion or varenicline Pregnancy or lactation
Facility Information:
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah DAUCHY, MD
Phone
33 1 42 11 40 53
Email
sarah.dauchy@igr.fr

12. IPD Sharing Statement

Links:
URL
http://www.igr.fr/
Description
Related Info

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Double-blind, Placebo-controlled, Randomized Study of the Effectiveness of Escitalopram on Emotional Distress of Head and Neck Cancer Patients During Cancer Treatment

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