Clinical trial NCT00536172: Evaluating the Effectiveness of Escitalopram to Prevent Depression in Head and Neck Cancer Patients Receiving Treatment
Official title: Prevention of Depression in Patients Being Treated for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Keywords: Antidepressant
Major depression
Prevention
Head and neck cancer
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-09-27
Enrollment: 160
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the effectiveness of escitalopram to prevent depression in head and neck cancer patients receiving treatment.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Depression as Assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16)
timeFrame: Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: William J Burke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lydiatt WM, Bessette D, Schmid KK, Sayles H, Burke WJ. Prevention of depression with escitalopram in patients undergoing treatment for head and neck cancer: randomized, double-blind, placebo-controlled clinical trial. JAMA Otolaryngol Head Neck Surg. 2013 Jul;139(7):678-86. doi: 10.1001/jamaoto.2013.3371.