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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00935675
First received: July 7, 2009
Last updated: September 1, 2009
Last verified: July 2009

July 7, 2009
September 1, 2009
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Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT00935675 on ClinicalTrials.gov Archive Site
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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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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

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Carcinomas
Drug: Escitalopram
Escitalopram 10 mg once a day
  • Active Comparator: Antidepressant treatment
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Placebo
    Intervention: Drug: Escitalopram
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
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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
Both
18 Years to 75 Years
No
France
 
NCT00935675
TADDOR, CSET 1388
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SARAH DAUCHY MD
Gustave Roussy, Cancer Campus, Grand Paris
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Gustave Roussy, Cancer Campus, Grand Paris
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP