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

Depression Clinical Trial

— PROTECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00536172
• Other study ID #: 0188-07-FB
• Secondary ID: R01MH079420DAHBR
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2007
• Est. completion date: June 1, 2012

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 1, 2012
• Est. primary completion date: June 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Head and Neck Neoplasms

Intervention

Drug:
• Escitalopram
Participants take 10 mg for 1 week and then 20 mg for 15 weeks.
• Placebo
Placebo distribution matches the active medication.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression as Assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16)	Number of participants reaching pre-defined threshold on the QIDS-SR-16 of >/=11. The QIDS-SR-16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores >/= 11 correspond to moderate to severe depression.	Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28