Clinical trial · Interventional
Double-blind, Placebo-controlled, Randomized Study of the Effectiveness of Escitalopram on Emotional Distress of Head and Neck Cancer Patients During Cancer Treatment
NCT00935675CI-TRIAL-00002594unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinomas | Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Escitalopram | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Antidepressant treatment
- interventionNames
- Drug: Escitalopram
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Escitalopram
Primary outcomes (1)
- measure
- Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDVita G, Compri B, Matcham F, Barbui C, Ostuzzi G. Antidepressants for the treatment of depression in people with cancer. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD011006. doi: 10.1002/14651858.CD011006.pub4. PMID 36999619