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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00935675
First Posted: July 9, 2009
Last Update Posted: September 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
July 7, 2009
July 9, 2009
September 2, 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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
 
Unknown status
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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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