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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William Burke, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00536172
First received: September 25, 2007
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Depression
Drug: Escitalopram
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Depression in Patients Being Treated for Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Depressive Symptoms as Assessed by the Quick Inventory of Depressive Symptomatology-Clinician Rated 16 (QIDS-C-16) [ Time Frame: Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28 ] [ Designated as safety issue: No ]
    Clinician-rated measure of a patient's depressive symptoms


Enrollment: 160
Study Start Date: December 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536172

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5580
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: William J. Burke, MD University of Nebraska
  More Information

Publications:
Responsible Party: William Burke, MD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT00536172     History of Changes
Other Study ID Numbers: R01 MH079420, R01MH079420, DAHBR 96-BHC
Study First Received: September 25, 2007
Results First Received: December 20, 2013
Last Updated: February 20, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Nebraska:
Antidepressant
Major depression
Prevention
Head and neck cancer

Additional relevant MeSH terms:
Depression
Depressive Disorder
Head and Neck Neoplasms
Behavioral Symptoms
Mood Disorders
Mental Disorders
Neoplasms by Site
Neoplasms
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on July 24, 2014