[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642469":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":45,"centralContacts":52,"locations":62,"responsibleParty":80,"collaborators":82,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":31,"enrollmentInfo":96,"targetDuration":31,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":110,"whyStopped":31,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Exercise+Duloxetine","ACTIVE_COMPARATOR","hybrid supervised aerobic exercise plus duloxetine",[13,14],"Behavioral: Exercise","Drug: Duloxetine",{"label":16,"type":10,"description":17,"interventionNames":18},"Duloxetine+PT referral","duloxetine plus physical therapy (PT) referral",[14,19],"Behavioral: PT referral",{"label":21,"type":10,"description":22,"interventionNames":23},"Exercise+Placebo","hybrid supervised aerobic exercise plus placebo",[13,24],"Drug: Placebo",[26,32,37,41],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","Exercise","Participants will be asked to participate in a 1x\u002Fweek center-based exercise session and 2x\u002Fweek walking session conducted on their own for \\~12 weeks.",[9,21],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"DRUG","Duloxetine","Participants will receive study medication - duloxetine - and take medication as directed.",[16,9],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"Placebo","Participants will receive study medication - matched placebo- and take as directed.",[21],{"type":27,"name":42,"description":43,"armGroupLabels":44,"otherNames":31},"PT referral","Participants will be referred to physical therapy with treatment as part of usual care and individualized to the Veteran's needs.",[16],[46,50],{"name":47,"affiliation":48,"role":49},"Alan M Rathbun, PhD MPH","Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD","PRINCIPAL_INVESTIGATOR",{"name":51,"affiliation":48,"role":49},"Alice S. Ryan, PhD",[53,58],{"name":54,"role":55,"phone":56,"phoneExt":31,"email":57},"Alice S Ryan, PhD","CONTACT","(410) 605-7851","Alice.Ryan@va.gov",{"name":59,"role":55,"phone":60,"phoneExt":31,"email":61},"Kristina Marcus, MS","(410) 605-7000","kristina.marcus@va.gov",[63],{"facility":48,"status":31,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Baltimore","Maryland","21201","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-76.61219,39.29038,{"lat":73,"lon":72},[76,78,79],{"name":54,"role":55,"phone":77,"phoneExt":31,"email":57},"410-605-7851",{"name":47,"role":49,"phone":31,"phoneExt":31,"email":31},{"name":51,"role":49,"phone":31,"phoneExt":31,"email":31},{"type":81,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[83],{"name":84,"class":6},"Baltimore VA Medical Center","100642469","phase-2-duloxetine-and-aerobic-exercise-to-improve-function-in-veterans-with-knee-osteoarthritis-drive-100642469",false,"NCT07649291","Duloxetine and aeRobic Exercise to Improve Function in VEterans With Knee Osteoarthritis (DRIVE)","Duloxetine Plus Exercise to Improve Physical Function in Veterans With Knee Osteoarthritis, Pain, and Psychological Comorbidity","DRIVE","Inclusion Criteria:\n\n* Veterans aged ≥40 years\n* English-speaking\n* symptomatic KOA based on American College of Rheumatology (ACR) criteria\n* Patient Health Questionnaire-9 (PHQ-9) scores indicating mild to severe depressive symptoms\n* no planned knee surgery within the next 6 months\n* ability to participate in supervised aerobic exercise\n\nExclusion Criteria:\n\n* current use of antidepressants, opioids, benzodiazepines, or antipsychotics\n* engaging in structured aerobic or resistance exercise ≥3 times per week\n* cognitive impairment defined as a Mini-Mental State Examination (MMSE) score \\\u003C20\n* diagnosis of bipolar disorder, psychosis, recent substance use disorder, or suicidal ideation per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)\n* medical conditions contraindicating exercise (e.g., recent myocardial infarction, unstable angina, peripheral arterial disease with ulcers, -uncontrolled hypertension \\>190\u002F110, or New York Heart Association class ≥3 cardiac or pulmonary disease)\n* pregnant or lactating individuals\n* active cancer that is currently undergoing treatment (receiving chemotherapy and\u002For radiation therapy\n* other conditions deemed by study team to endanger the health of the participant",true,"ALL","40 Years",{"count":97,"type":98},102,"ESTIMATED","INTERVENTIONAL",[101],"PHASE2","Knee osteoarthritis (KOA) is one of the most common causes of chronic pain, mobility problems, and disability among United States Veterans. Many Veterans with KOA also experience depressive symptoms, which can worsen pain, reduce motivation to exercise, and make recovery more difficult. This study will test whether a structured hybrid aerobic exercise program that combines supervised and home-based walking with the medication duloxetine can improve physical function, reduce pain, lessen depressive symptoms, and improve overall health-related outcomes in Veterans with KOA. The goal of this research is to develop a practical and scalable treatment strategy that could improve rehabilitation and quality of life for Veterans with chronic knee pain and depressive symptoms and potentially be adapted for other chronic musculoskeletal conditions treated within the VA healthcare system.",[104,105,106],"Knee Osteoarthritis","Pain","Depression",[28,105,108,109,34],"Depressive symptoms","Physical Function","NOT_YET_RECRUITING","2026-06-10",{"date":113,"type":114},"2026-06-16","ACTUAL",{"date":116,"type":98},"2027-03-01",{"date":118,"type":98},"2032-09-01",{"name":5,"class":6},1]