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Duloxetine and Aerobic Exercise for Veterans with Knee Osteoarthritis

This study, called DRIVE, is for Veterans with knee osteoarthritis (KOA), a common cause of chronic pain and mobility problems, who also experience symptoms of depression. Researchers want to see if combining a structured exercise program with the medication duloxetine can improve physical function, reduce pain, and lessen depressive symptoms. You would either receive duloxetine, a placebo (an inactive pill that looks like the study drug), or be referred to physical therapy as part of your usual care. The exercise involves one weekly supervised session and two at-home walking sessions for about 12 weeks. The main goal is to see how your walking ability changes over 12 weeks. This study aims to enroll 102 Veterans.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 102 participants.
What's involved
Participants will attend one weekly center-based exercise session and do two weekly walking sessions on their own for about 12 weeks. You will also take study medication (duloxetine or placebo) as directed.
Compensation
Not stated in the trial record.
Follow-up
Your walking ability will be measured at the beginning of the study and again after 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07649291

Duloxetine and aeRobic Exercise to Improve Function in VEterans With Knee Osteoarthritis (DRIVE)

Not Yet Recruiting
PHASE2Ages 40+InterventionalTreatment
VA Office of Research and Development
~102 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:ExerciseDuloxetinePlaceboPT referral

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
20-Meter Walk Test
Measured over baseline, 12-week follow-up

Conditions

Knee Osteoarthritis
Pain
Depression

Explore related trials

DepressionOsteoarthritis of knee

NCT07649291

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    Baltimore, Marylandstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Alan M Rathbun, PhD MPH · PRINCIPAL_INVESTIGATOR · Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
  • Alice S. Ryan, PhD · PRINCIPAL_INVESTIGATOR · Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Who to contact

Alice S Ryan, PhD
[email protected]
(410) 605-7851
Email the study team

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Eligibility criteria

Inclusion

Veterans aged ≥40 years
English-speaking
symptomatic KOA based on American College of Rheumatology (ACR) criteria
Patient Health Questionnaire-9 (PHQ-9) scores indicating mild to severe depressive symptoms
no planned knee surgery within the next 6 months
ability to participate in supervised aerobic exercise

Exclusion

current use of antidepressants, opioids, benzodiazepines, or antipsychotics
engaging in structured aerobic or resistance exercise ≥3 times per week
cognitive impairment defined as a Mini-Mental State Examination (MMSE) score \<20
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)
medical conditions contraindicating exercise (e.g., recent myocardial infarction, unstable angina, peripheral arterial disease with ulcers, -uncontrolled hypertension \>190/110, or New York Heart Association class ≥3 cardiac or pulmonary disease)
pregnant or lactating individuals
active cancer that is currently undergoing treatment (receiving chemotherapy and/or radiation therapy
other conditions deemed by study team to endanger the health of the participant

What this trial measures

  • 20-Meter Walk Testbaseline, 12-week follow-up

    20m WT (average time to walk 20 meters at usual pace across two trials) from baseline to 12 weeks, and between-group comparison (aerobic exercise + duloxetine vs. PT referral + duloxetine)