Status:
UNKNOWN
Double-blind, Placebo-controlled, Randomized Study of the Effectiveness of Escitalopram on Emotional Distress of Head and Neck Cancer Patients During Cancer Treatment
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Carcinomas
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Head and neck squamous cell carcinomas, stage I to IVb
- First-line curative cancer therapy : surgery and/or brachytherapy and/or chemotherapy
- HADS- T \>11
- Aged 18 to 75 yo, written consent required
- OMS\>2
Exclusion
- Palliative care
- Previous head and neck cancer
- Bipolar disorder or schizophrenia
- Severe major depressive disorder (DSM-IV TR)
- Expressed suicidal ideation
- Severe untreated organic disorder, especially acute infectious disorder
- ASAT/ALAT \> 3N
- Clearance of creatinin \< 30 ml/mn
- Hyponatremia
- Antecedent of delirium tremens or acute alcohol withdrawal disorder
- Antecedent of upper gastro-intestinal bleeding
- Antecedent of toxicity or inefficacy of a previous treatment with escitalopram
- Unauthorized treatments :- Antidepressant or antiepileptic (clonazepam authorized)- Hypnotic except zolpidem - Anxiolytic except clonazepam, clorazepate or diazepam- bupropion or varenicline
- Pregnancy or lactation
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00935675
Last Update
September 2 2009
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, 94800