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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00536172 |
This study will evaluate the effectiveness of escitalopram to prevent depression in head and neck cancer patients receiving treatment.
Condition | Intervention | Phase |
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Depression |
Drug: Escitalopram Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Prevention of Depression in Patients Being Treated for Head and Neck Cancer |
Estimated Enrollment: | 188 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Participants will receive treatment with escitalopram
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Drug: Escitalopram
Participants take 10 mg for 1 week and then 20 mg for 15 weeks.
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B: Placebo Comparator
Participants will receive treatment with placebo
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Drug: Placebo
Placebo distribution matches the active medication.
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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.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Nebraska | |
University of Nebraska Medical Center | Recruiting |
Omaha, Nebraska, United States, 68198-5580 | |
Contact: William J. Burke, MD 402-552-6063 wjburke@unmc.edu | |
Contact: Rosella Squires 402-552-6005 rsquires@unmc.edu | |
Principal Investigator: William J. Burke, MD |
Principal Investigator: | William J. Burke, MD | University of Nebraska |
Responsible Party: | University of Nebraska Medical Center ( William J. Burke, MD/Principal Investigator ) |
Study ID Numbers: | R01 MH079420, DAHBR 96-BHC |
Study First Received: | September 25, 2007 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00536172 History of Changes |
Health Authority: | United States: Federal Government |
Antidepressant Major depression Prevention Head and neck cancer |
Neurotransmitter Agents Depression Cholinergic Antagonists Psychotropic Drugs Depressive Disorder, Major Cholinergic Agents Depressive Disorder Serotonin Uptake Inhibitors Citalopram Serotonin |
Behavioral Symptoms Muscarinic Antagonists Mental Disorders Head and Neck Neoplasms Mood Disorders Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Dexetimide Antidepressive Agents |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents Neoplasms by Site Mental Disorders Therapeutic Uses Dexetimide Antidepressive Agents, Second-Generation |
Antidepressive Agents Depression Depressive Disorder Serotonin Uptake Inhibitors Citalopram Pharmacologic Actions Behavioral Symptoms Muscarinic Antagonists Neoplasms Serotonin Agents Autonomic Agents Head and Neck Neoplasms Mood Disorders Peripheral Nervous System Agents Central Nervous System Agents |