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

Gustave Roussy

Status and phase: Unknown; Phase 3

Conditions: Carcinomas

Treatments: Drug: Escitalopram

Study type: Interventional

Funder types: Other

Identifiers

NCT00935675

TADDOR

CSET 1388

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Antidepressant treatment

Active Comparator group

Treatment:

Drug: Escitalopram

Placebo

Placebo Comparator group

Treatment:

Drug: Escitalopram