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.