Duloxetine + Exercise for Osteoarthritis

(DRIVE Trial)

AS
KM
Overseen ByKristina Marcus, MS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

AM

Alan M Rathbun, PhD MPH

Principal Investigator

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

AS

Alice S. Ryan, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

Inclusion Criteria

Patient Health Questionnaire-9 (PHQ-9) scores indicating mild to severe depressive symptoms
English-speaking
I am able to take part in supervised aerobic exercise.
See 3 more

Exclusion Criteria

I am currently taking antidepressants, opioids, benzodiazepines, or antipsychotics.
Pregnant or lactating individuals
Other conditions deemed by study team to endanger the health of the participant
See 5 more

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

3

Treatment groups

Active Control

Group I: Exercise+DuloxetineActive Control2 Interventions
Group II: Duloxetine+PT referralActive Control2 Interventions
Group III: Exercise+PlaceboActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Baltimore VA Medical Center

Collaborator

Trials
33
Recruited
3,000+