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

Phase 3

• Conditions: Carcinomas
• Interventions: Drug: Escitalopram

• Registration Number: NCT00935675
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-07
• Study First Submitted: 2009-07-07
• Study First Submitted QC: 2009-07-08
• Study First Posted: 2009-07-09
• Last Update Submitted: 2009-09-01
• Last Update Posted: 2009-09-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Escitalopram	-
Antidepressant treatment	Escitalopram	-

Primary Outcome Measures

Name	Time	Method
Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months	3 months

Trial Locations

Locations (1)

Institut Gustave Roussy; 🇫🇷 Villejuif, France