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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00536172
Recruitment Status : Completed
First Posted : September 27, 2007
Results First Posted : February 14, 2014
Last Update Posted : February 2, 2018
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
William Burke, MD, University of Nebraska

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

Condition or disease Intervention/treatment Phase
Depression Drug: Escitalopram Drug: Placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Depression in Patients Being Treated for Head and Neck Cancer
Study Start Date : December 2007
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Escitalopram
Participants will receive treatment with escitalopram
Drug: Escitalopram
Participants take 10 mg for 1 week and then 20 mg for 15 weeks.
Other Name: Lexapro
Placebo Comparator: Placebo
Participants will receive treatment with placebo
Drug: Placebo
Placebo distribution matches the active medication.
Other Names:
  • Sugar pill
  • Inactive substance

Primary Outcome Measures :
  1. Depression as Assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16) [ Time Frame: Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28 ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00536172

United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5580
Sponsors and Collaborators
University of Nebraska
National Institute of Mental Health (NIMH)
Principal Investigator: William J. Burke, MD University of Nebraska

Publications of Results:
Responsible Party: William Burke, MD, Principal Investigator, University of Nebraska Identifier: NCT00536172     History of Changes
Other Study ID Numbers: 188-07
R01MH079420 ( U.S. NIH Grant/Contract )
First Posted: September 27, 2007    Key Record Dates
Results First Posted: February 14, 2014
Last Update Posted: February 2, 2018
Last Verified: January 2018

Keywords provided by William Burke, MD, University of Nebraska:
Major depression
Head and neck cancer

Additional relevant MeSH terms:
Depressive Disorder
Head and Neck Neoplasms
Behavioral Symptoms
Mood Disorders
Mental Disorders
Neoplasms by Site
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents