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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 because the information has not been verified recently.
Verified July 2009 by Institut Gustave Roussy.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT00935675
First received: July 7, 2009
Last updated: September 1, 2009
Last verified: July 2009
History of Changes
  Purpose

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
Carcinomas
 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:

U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Institut Gustave Roussy
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: SARAH DAUCHY MD
ClinicalTrials.gov 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 Institut Gustave Roussy:
Patients with head and neck squamous cell carcinomas
head and neck squamous cell carcinomas

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

ClinicalTrials.gov processed this record on May 19, 2013