NCT00935675
Unknown
Phase 3
Double-blind, Placebo-controlled, Randomized Study of the Effectiveness of Escitalopram on Emotional Distress of Head and Neck Cancer Patients During Cancer Treatment
Overview
- Phase
- Phase 3
- Intervention
- Escitalopram
- Conditions
- Carcinomas
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months
- Last Updated
- 16 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Antidepressant treatment
Intervention: Escitalopram
Placebo
Intervention: Escitalopram
Outcomes
Primary Outcomes
Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months
Time Frame: 3 months
Study Sites (1)
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