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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00935675

Enrollment

100

Registered

2009-07-09

Start date

Unknown

Completion date

Unknown

Last updated

2009-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinomas

Keywords

Patients with head and neck squamous cell carcinomas, head and neck squamous cell carcinomas

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

Interventions

DRUGEscitalopram

Escitalopram 10 mg once a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months	3 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026