Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01MH079420 | U.S. NIH Grant/Contract | View source | |
| DAHBR 96-BHC | Other Grant/Funding Number | National Institute of Mental Health (NIMH) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the effectiveness of escitalopram to prevent depression in head and neck cancer patients receiving treatment.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escitalopram | Experimental | Participants will receive treatment with escitalopram |
|
| Placebo | Placebo Comparator | Participants will receive treatment with placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | Participants take 10 mg for 1 week and then 20 mg for 15 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| William J Burke, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23788218 | Result | 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. | |
| 36999619 | Derived | 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. |
Not provided
Not provided
12 of the 160 subjects who agreed to participate were not eligible: 9 QIDS or QIDS-C >/=11; 1 not able/willing to return for follow-up; 1 received antidepressants in the past week; 1 not diagnosed with epidermoid cancer and meets MINI criteria for depression. The remaining 148 subjects were randomized.
298 patients were screened for possible study eligibility from January 6, 2008, to December 28, 2011. 160 subjects agreed to participate.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Escitalopram | Participants will receive treatment with escitalopram Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks. |
| FG001 | Placebo | Participants will receive treatment with placebo Placebo: Placebo distribution matches the active medication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Escitalopram | Participants will receive treatment with escitalopram Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks. |
| BG001 | Placebo | Participants will receive treatment with placebo Placebo: Placebo distribution matches the active medication. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Evaluable subjects | Posted | Number | participants | Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28 |
|
16 weeks of blinded and 12 weeks of open-label treatment
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Escitalopram | Participants will receive treatment with escitalopram Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and vomiting | Gastrointestinal disorders | FISER-GRSEB | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | FISER-GRSEB | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Burke MD | University of Nebraska | 4025526005 | wjburke@Unmc.edu |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo distribution matches the active medication. |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Clinical Stage | Clinical stage of cancer done using the AJCC manual on staging (2008 edition), based on TNM system. T stands for tumor (by size or extension into adjacent structures or subsites), N stands for nodal burden, M stands for distant metastasis (0 for none or 1 for any). Stage is assigned using all clinical material available to the surgeon at time of entry. Prognosis is dependent on stage and site of disease. Stage 1 was not allowed in the study due to very good prognosis and less treatment morbidity. Stage II is early stage disease. Late stage is III, IVA, IVB and IVC. | Number | participants |
|
| Cancer Site | anatomical location of tumor | Number | participants |
|
| Cancer Type | Number | participants |
|
| Initial Treatment Type (Surgery or Radiation) | Number | participants |
|
Participants will receive treatment with placebo
Placebo: Placebo distribution matches the active medication.
|
|
| 16 |
| 74 |
| 16 |
| 74 |
| 47 |
| 74 |
| EG001 | Placebo | Participants will receive treatment with placebo Placebo: Placebo distribution matches the active medication. | 13 | 74 | 13 | 74 | 49 | 74 |
| Confusion | Nervous system disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Dehydration | General disorders | FISER-GRSEB | Non-systematic Assessment | Secondary to diarrhea |
|
| Atrial Fibrillation | Cardiac disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Chest Pain | Cardiac disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Fever | General disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Pain | General disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Fractured Leg | Musculoskeletal and connective tissue disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Acute Renal Failure | Renal and urinary disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Dizziness/Syncope/Fall | General disorders | FISER-GRSEB | Non-systematic Assessment |
|
| GI Bleed | Gastrointestinal disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Mental Status Change | Nervous system disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Wound Infection | Infections and infestations | FISER-GRSEB | Non-systematic Assessment |
|
| Coronary Stenosis | Cardiac disorders | FISER-GRSEB | Non-systematic Assessment |
|
| G-tube Procedure Monitoring | General disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Insomnia | General disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Mucositis | General disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Nausea and vomiting | General disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | FISER-GRSEB | Non-systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | FISER-GRSEB | Non-systematic Assessment |
|
Not provided
Not provided
| D001523 |
| Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |