Double-blind, Placebo-controlled, Randomized Study of the Effectiveness of Escitalopram on Emotional Distress of Head and Neck Cancer Patients During Cancer Treatment
NCT ID: NCT00935675
Last Updated: 2009-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Antidepressant treatment
Escitalopram
Escitalopram 10 mg once a day
Placebo
Escitalopram
Escitalopram 10 mg once a day
Interventions
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Escitalopram
Escitalopram 10 mg once a day
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Locations
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Institut Gustave Roussy
Villejuif, , France
Countries
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Facility Contacts
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References
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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.
Related Links
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Related Info
Other Identifiers
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CSET 1388
Identifier Type: -
Identifier Source: secondary_id
TADDOR
Identifier Type: -
Identifier Source: org_study_id
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