{"protocolSection":{"identificationModule":{"nctId":"NCT00536172","orgStudyIdInfo":{"id":"0188-07-FB"},"secondaryIdInfos":[{"id":"R01MH079420","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01MH079420"},{"id":"DAHBR 96-BHC","type":"OTHER_GRANT","domain":"National Institute of Mental Health (NIMH)"}],"organization":{"fullName":"University of Nebraska","class":"OTHER"},"briefTitle":"Evaluating the Effectiveness of Escitalopram to Prevent Depression in Head and Neck Cancer Patients Receiving Treatment","officialTitle":"Prevention of Depression in Patients Being Treated for Head and Neck Cancer","acronym":"PROTECT"},"statusModule":{"statusVerifiedDate":"2023-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-12-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2012-06-01","type":"ACTUAL"},"completionDateStruct":{"date":"2012-06-01","type":"ACTUAL"},"studyFirstSubmitDate":"2007-09-25","studyFirstSubmitQcDate":"2007-09-26","studyFirstPostDateStruct":{"date":"2007-09-27","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-12-20","resultsFirstSubmitQcDate":"2013-12-20","resultsFirstPostDateStruct":{"date":"2014-02-14","type":"ESTIMATED"},"lastUpdateSubmitDate":"2023-09-08","lastUpdatePostDateStruct":{"date":"2023-09-21","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of Nebraska","class":"OTHER"},"collaborators":[{"name":"National Institute of Mental Health (NIMH)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study will evaluate the effectiveness of escitalopram to prevent depression in head and neck cancer patients receiving treatment.","detailedDescription":"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.\n\nAll 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."},"conditionsModule":{"conditions":["Depression"],"keywords":["Antidepressant","Major depression","Prevention","Head and neck cancer"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"PREVENTION","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":160,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Escitalopram","type":"EXPERIMENTAL","description":"Participants will receive treatment with escitalopram","interventionNames":["Drug: Escitalopram"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants will receive treatment with placebo","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Escitalopram","description":"Participants take 10 mg for 1 week and then 20 mg for 15 weeks.","armGroupLabels":["Escitalopram"],"otherNames":["Lexapro"]},{"type":"DRUG","name":"Placebo","description":"Placebo distribution matches the active medication.","armGroupLabels":["Placebo"],"otherNames":["Sugar pill","Inactive substance"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Depression as Assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16)","description":"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.","timeFrame":"Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Newly diagnosed or recurrent epidermoid cancer of the head and neck\n* Requires more than minimal therapy for treatment\n* Able to read and write in English\n* Willing to use an effective form of birth control throughout the study\n\nExclusion Criteria:\n\n* Meets MINI criteria for major depression, schizophrenia, or bipolar illness or scores 24 or less\n* Suicidal or psychotic\n* Current allergy or hypersensitivity to citalopram or other SSRIs\n* Treated with monoamine oxidase inhibitors 14 days prior to study entry\n* Use of antidepressants within 1 week of study entry\n* Pregnant or breastfeeding\n* History of an adequate cancer operation, radiation, or chemotherapy within 6 months of study entry\n* Diagnosed with melanoma or lymphoma cancer of the head and neck\n* Currently participating in another research study involving a therapeutic intervention","healthyVolunteers":false,"sex":"ALL","minimumAge":"19 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"William J Burke, MD","affiliation":"University of Nebraska","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Nebraska Medical Center","city":"Omaha","state":"Nebraska","zip":"68198","country":"United States","geoPoint":{"lat":41.25626,"lon":-95.94043}}]},"referencesModule":{"references":[{"pmid":"23788218","type":"RESULT","citation":"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."},{"pmid":"36999619","type":"DERIVED","citation":"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."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"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.","recruitmentDetails":"298 patients were screened for possible study eligibility from January 6, 2008, to December 28, 2011. 160 subjects agreed to participate.","groups":[{"id":"FG000","title":"Escitalopram","description":"Participants will receive treatment with escitalopram\n\nEscitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."},{"id":"FG001","title":"Placebo","description":"Participants will receive treatment with placebo\n\nPlacebo: Placebo distribution matches the active medication."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"74"},{"groupId":"FG001","numSubjects":"74"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"60"},{"groupId":"FG001","numSubjects":"65"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"9"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Escitalopram","description":"Participants will receive treatment with escitalopram\n\nEscitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."},{"id":"BG001","title":"Placebo","description":"Participants will receive treatment with placebo\n\nPlacebo: Placebo distribution matches the active medication."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"74"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"148"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"63.2","spread":"11.3"},{"groupId":"BG001","value":"62.8","spread":"12.5"},{"groupId":"BG002","value":"63.0","spread":"11.9"}]}]}]},{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"43"},{"groupId":"BG002","value":"85"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"32"},{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"63"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"30"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"59"},{"groupId":"BG001","value":"59"},{"groupId":"BG002","value":"118"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"72"},{"groupId":"BG001","value":"71"},{"groupId":"BG002","value":"143"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"72"},{"groupId":"BG001","value":"73"},{"groupId":"BG002","value":"145"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"74"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"148"}]}]}]},{"title":"Clinical Stage","description":"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.","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"II","categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"35"}]}]},{"title":"III/IV","categories":[{"measurements":[{"groupId":"BG000","value":"57"},{"groupId":"BG001","value":"56"},{"groupId":"BG002","value":"113"}]}]}]},{"title":"Cancer Site","description":"anatomical location of tumor","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"oral","categories":[{"measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"36"},{"groupId":"BG002","value":"65"}]}]},{"title":"pharynx","categories":[{"measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"49"}]}]},{"title":"skin","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"17"}]}]},{"title":"salivary gland","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"11"}]}]},{"title":"sinus","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"6"}]}]}]},{"title":"Cancer Type","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"squamous cell","categories":[{"measurements":[{"groupId":"BG000","value":"65"},{"groupId":"BG001","value":"67"},{"groupId":"BG002","value":"132"}]}]},{"title":"salivary gland","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"10"}]}]},{"title":"skin","categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"4"}]}]},{"title":"missing","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"}]}]}]},{"title":"Initial Treatment Type (Surgery or Radiation)","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"surgery, not biopsy","categories":[{"measurements":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"81"}]}]},{"title":"radiation with/without chemotherapy","categories":[{"measurements":[{"groupId":"BG000","value":"32"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"67"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Depression as Assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16)","description":"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.","populationDescription":"Evaluable subjects","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28","groups":[{"id":"OG000","title":"Escitalopram","description":"Participants will receive treatment with escitalopram\n\nEscitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."},{"id":"OG001","title":"Placebo","description":"Participants will receive treatment with placebo\n\nPlacebo: Placebo distribution matches the active medication."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"65"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"16"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"16 weeks of blinded and 12 weeks of open-label treatment","eventGroups":[{"id":"EG000","title":"Escitalopram","description":"Participants will receive treatment with escitalopram\n\nEscitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks.","deathsNumAffected":16,"deathsNumAtRisk":74,"seriousNumAffected":16,"seriousNumAtRisk":74,"otherNumAffected":47,"otherNumAtRisk":74},{"id":"EG001","title":"Placebo","description":"Participants will receive treatment with placebo\n\nPlacebo: Placebo distribution matches the active medication.","deathsNumAffected":13,"deathsNumAtRisk":74,"seriousNumAffected":13,"seriousNumAtRisk":74,"otherNumAffected":49,"otherNumAtRisk":74}],"seriousEvents":[{"term":"Nausea and vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"FISER-GRSEB","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":2,"numAtRisk":74},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74}]},{"term":"Confusion","organSystem":"Nervous system disorders","sourceVocabulary":"FISER-GRSEB","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":74}]},{"term":"Pneumonia","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"FISER-GRSEB","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":74},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74}]},{"term":"Hyponatremia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"FISER-GRSEB","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":74},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74}]},{"term":"Dehydration","organSystem":"General disorders","sourceVocabulary":"FISER-GRSEB","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Secondary to diarrhea","stats":[{"groupId":"EG000","numEvents":5,"numAffected":4,"numAtRisk":74},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":74}]},{"term":"Atrial Fibrillation","organSystem":"Cardiac 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