Evaluating the Effectiveness of Escitalopram to Prevent Depression in Head and Neck Cancer Patients Receiving Treatment

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 intervention