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Clinical Trials/NCT00935675
NCT00935675
Unknown
Phase 3

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, Cancer Campus, Grand Paris1 site in 1 country100 target enrollmentJuly 9, 2009
ConditionsCarcinomas
InterventionsEscitalopram

Overview

Phase
Phase 3
Intervention
Escitalopram
Conditions
Carcinomas
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Enrollment
100
Locations
1
Primary Endpoint
Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months
Last Updated
16 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 9, 2009
End Date
TBD
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Head and neck squamous cell carcinomas, stage I to IVb
  • First-line curative cancer therapy : surgery and/or brachytherapy and/or chemotherapy
  • HADS- T \>11
  • Aged 18 to 75 yo, written consent required

Exclusion Criteria

  • Palliative care
  • Previous head and neck cancer
  • Bipolar disorder or schizophrenia
  • Severe major depressive disorder (DSM-IV TR)
  • Expressed suicidal ideation
  • Severe untreated organic disorder, especially acute infectious disorder
  • ASAT/ALAT \> 3N
  • Clearance of creatinin \< 30 ml/mn
  • Hyponatremia
  • Antecedent of delirium tremens or acute alcohol withdrawal disorder

Arms & Interventions

Antidepressant treatment

Intervention: Escitalopram

Placebo

Intervention: Escitalopram

Outcomes

Primary Outcomes

Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months

Time Frame: 3 months

Study Sites (1)

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