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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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ClinicalTrials.gov Identifier: NCT00935675
Recruitment Status : Unknown
Verified July 2009 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
First Posted : July 9, 2009
Last Update Posted : September 2, 2009
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris

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

Condition or disease Intervention/treatment Phase
Carcinomas Drug: Escitalopram Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment


Arm Intervention/treatment
Active Comparator: Antidepressant treatment Drug: Escitalopram
Escitalopram 10 mg once a day

Placebo Comparator: Placebo Drug: Escitalopram
Escitalopram 10 mg once a day




Primary Outcome Measures :
  1. Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935675


Locations
France
Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Contact: Sarah DAUCHY, MD    33 1 42 11 40 53    sarah.dauchy@igr.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris

Additional Information:
Responsible Party: SARAH DAUCHY MD
ClinicalTrials.gov Identifier: NCT00935675     History of Changes
Other Study ID Numbers: TADDOR
CSET 1388
First Posted: July 9, 2009    Key Record Dates
Last Update Posted: September 2, 2009
Last Verified: July 2009

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Patients with head and neck squamous cell carcinomas
head and neck squamous cell carcinomas

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents