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NCT00935675 Clinical Trial

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

Carcinomas Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00935675
Other study ID # TADDOR
Secondary ID CSET 1388
Status Recruiting
Phase Phase 3
First received July 7, 2009
Last updated September 1, 2009

Study information
Verified date July 2009
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Escitalopram
Escitalopram 10 mg once a day

Locations
Country Name City State
France Institut Gustave Roussy Villejuif

Sponsors (1)
Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months 3 months
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