Double-blind, Placebo-controlled, Randomized Study of the Effectiveness of Escitalopram on Emotional Distress of Head and Neck Cancer Patients During Cancer Treatment

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00935675
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Carcinomas	Drug: Escitalopram	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Antidepressant treatment	Drug: Escitalopram; Escitalopram 10 mg once a day
Placebo Comparator: Placebo	Drug: Escitalopram; Escitalopram 10 mg once a day

Outcome Measures

Primary Outcome Measures

1. Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Gustave Roussy	Villejuif		France	94800

Sponsors and Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00935675
• Other Study ID Numbers: TADDOR; CSET 1388
• First Posted: Jul 9, 2009
• Last Update Posted: Sep 2, 2009
• Last Verified: Jul 1, 2009

• Keywords provided by , ,: Patients with head and neck squamous cell carcinomas; head and neck squamous cell carcinomas
• Additional relevant MeSH terms: Carcinoma; Citalopram

Study Results

No Results Posted as of Sep 2, 2009