Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris Identifier:
First received: July 7, 2009
Last updated: September 1, 2009
Last verified: July 2009
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 Intervention Phase
Drug: Escitalopram
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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

Estimated Enrollment: 100
Arms Assigned Interventions
Active Comparator: Antidepressant treatment Drug: Escitalopram
Escitalopram 10 mg once a day
Placebo Comparator: Placebo Drug: Escitalopram
Escitalopram 10 mg once a day


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00935675

Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Contact: Sarah DAUCHY, MD    33 1 42 11 40 53   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Additional Information:
Responsible Party: SARAH DAUCHY MD Identifier: NCT00935675     History of Changes
Other Study ID Numbers: TADDOR  CSET 1388 
Study First Received: July 7, 2009
Last Updated: September 1, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
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
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents processed this record on October 21, 2016