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

NCT ID: NCT00536172

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-01
• Study Completion Date: 2012-06-01

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Escitalopram

Participants will receive treatment with escitalopram

Group Type: EXPERIMENTAL

Escitalopram

Intervention Type: DRUG

Participants take 10 mg for 1 week and then 20 mg for 15 weeks.

Placebo

Participants will receive treatment with placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo distribution matches the active medication.

Interventions

Escitalopram

Participants take 10 mg for 1 week and then 20 mg for 15 weeks.

Intervention Type: DRUG

Placebo

Placebo distribution matches the active medication.

Intervention Type: DRUG

Other Intervention Names

Lexapro; Sugar pill; Inactive substance

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William J Burke, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23788218 (View on PubMed)

Vita G, Compri B, Matcham F, Barbui C, Ostuzzi G. Antidepressants for the treatment of depression in people with cancer. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD011006. doi: 10.1002/14651858.CD011006.pub4.

Reference Type: DERIVED

PMID: 36999619 (View on PubMed)

Other Identifiers

R01MH079420

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DAHBR 96-BHC

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0188-07-FB

Identifier Type: -

Identifier Source: org_study_id