NCT00935675

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
Last Updated

September 2, 2009

Status Verified

July 1, 2009

First QC Date

July 7, 2009

Last Update Submit

September 1, 2009

Conditions

Carcinomas

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

    3 months

Study Arms (2)

Antidepressant treatment

ACTIVE COMPARATOR
Drug: Escitalopram

Placebo

PLACEBO COMPARATOR
Drug: Escitalopram

Interventions

EscitalopramDRUG

Escitalopram 10 mg once a day

Antidepressant treatmentPlacebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • OMS\>2

You may not qualify if:

  • 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
  • Antecedent of upper gastro-intestinal bleeding
  • Antecedent of toxicity or inefficacy of a previous treatment with escitalopram
  • Unauthorized treatments :- Antidepressant or antiepileptic (clonazepam authorized)- Hypnotic except zolpidem - Anxiolytic except clonazepam, clorazepate or diazepam- bupropion or varenicline
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94800, France

RECRUITING

Related Publications (1)

  • Vita 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: 36999619DERIVED

Related Links

MeSH Terms

Conditions

CarcinomaSquamous Cell Carcinoma of Head and Neck

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsCarcinoma, Squamous CellHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 9, 2009

Last Updated

September 2, 2009

Record last verified: 2009-07

Locations

FR(1)