Double-blind, Placebo-controlled, Randomized Study of the Effectiveness of Escitalopram on Emotional Distress of Head and Neck Cancer Patients During Cancer Treatment

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Treatments: Citalopram; Dexetimide

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