- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00935675
Double-blind, Placebo-controlled, Randomized Study of the Effectiveness of Escitalopram on Emotional Distress of Head and Neck Cancer Patients During Cancer Treatment
September 1, 2009 updated by: Gustave Roussy, Cancer Campus, Grand Paris
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
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Villejuif, France, 94800
- Recruiting
- Institut Gustave Roussy
-
Contact:
- Sarah DAUCHY, MD
- Phone Number: 33 1 42 11 40 53
- Email: sarah.dauchy@igr.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
- OMS>2
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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Escitalopram 10 mg once a day
|
Active Comparator: Antidepressant treatment
|
Escitalopram 10 mg once a day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
July 7, 2009
First Submitted That Met QC Criteria
July 8, 2009
First Posted (Estimate)
July 9, 2009
Study Record Updates
Last Update Posted (Estimate)
September 2, 2009
Last Update Submitted That Met QC Criteria
September 1, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Carcinoma
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- TADDOR
- CSET 1388
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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