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Prevention of Depression in Patients Being Treated for Head and Neck Cancer

Phase 4
19 Years
Not Enrolling

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Trial Information

Prevention of Depression in Patients Being Treated for Head and Neck Cancer

Most types of head and neck cancer develop in the lining of cells found within many parts of
the head and neck. Each year, more than 40,000 adults are diagnosed with head and neck
cancer in the United States. The leading cause of this type of cancer is tobacco use. Common
signs and symptoms of head and neck cancer include blood in saliva; frequent nose bleeds;
and difficulty chewing, swallowing, or breathing. Effective treatments for head and neck
cancer are available if the cancer is found in its early stages. However, treatment is
difficult, causing many people to become depressed within 3 months of being diagnosed.
Unfortunately, depression can lead to delays in treatment, impair quality of life, and
decrease long-term survival. The purpose of this study is to determine whether the use of
antidepressant medication initiated prior to starting treatment will prevent the onset of
depression during treatment in non-depressed head and neck cancer patients. This study will
also determine if escitalopram will maintain quality of life during treatment, improve
participation in treatment, decrease delays and premature discontinuation of treatment, and
reduce alcohol and tobacco use in patients with head and neck cancer.

All participants will attend an initial screening, followed by eight clinic visits. The
first clinic visit will include completion of an interview and brief questionnaires
regarding depression, mental and emotional health, alcohol and tobacco use, and quality of
life. Participants will then be randomly assigned to receive 16 weeks of the antidepressant
escitalopram or a placebo pill. Participants will take 10 mg of their assigned medication
every day for the first week and then 20 mg of their assigned medication every day for the
remaining 15 weeks. Participants will visit the clinic every 2 weeks during treatment, at
which time they will answer questions similar to those asked at the initial visit. Any
medication side effects will also be recorded at each visit. Once treatment has been
completed, participants will visit the clinic three more times over a period of 12 weeks.
Similar questions as those at treatment visits will be asked. Results from this study will
be used to assess whether depression is preventable in head and neck cancer patients if
antidepressant medication is initiated before treatment begins.

Inclusion Criteria:

- Newly diagnosed or recurrent epidermoid cancer of the head and neck

- Requires more than minimal therapy for treatment

- Able to read and write in English

- Willing to use an effective form of birth control throughout the study

Exclusion Criteria:

- Meets MINI criteria for major depression, schizophrenia, or bipolar illness or scores
24 or less

- Suicidal or psychotic

- Current allergy or hypersensitivity to citalopram or other SSRIs

- Treated with monoamine oxidase inhibitors 14 days prior to study entry

- Use of antidepressants within 1 week of study entry

- Pregnant or breastfeeding

- History of an adequate cancer operation, radiation, or chemotherapy within 6 months
of study entry

- Diagnosed with melanoma or lymphoma cancer of the head and neck

- Currently participating in another research study involving a therapeutic

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Depression as assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16)

Outcome Time Frame:

Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28

Safety Issue:


Principal Investigator

William J. Burke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska


United States: Federal Government

Study ID:

R01 MH079420



Start Date:

December 2007

Completion Date:

June 2012

Related Keywords:

  • Depression
  • Antidepressant
  • Major depression
  • Prevention
  • Head and neck cancer
  • Depression
  • Depressive Disorder
  • Head and Neck Neoplasms



University of Nebraska Medical Center Omaha, Nebraska  68198-3330