Exercise Plus Duloxetine for Knee Osteoarthritis (NCT04111627) | Clinical Trial Compass
CompletedPhase 2
Exercise Plus Duloxetine for Knee Osteoarthritis
United States43 participantsStarted 2021-10-07
Plain-language summary
This study evaluates the addition of duloxetine to aerobic exercise in the treatment of symptomatic knee osteoarthritis and depressive symptoms in adults. All participants will receive the receive the treatment protocol, which will first be evaluated in terms of feasibility and then pilot tested.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. English speaking
. 40 years or older
. Symptomatic knee osteoarthritis fulfilling 1986 American College of Rheumatology criteria
. No plan for surgical knee osteoarthritis intervention within six months of enrollment
. Major depressive disorder satisfying diagnostic criteria according to the DSM-V
. Ability to participate in a supervised aerobic exercise program
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Already performing aerobic or resistive exercise 2x/week or more
. Taking duloxetine, antipsychotics, benzodiazepines, or opioid analgesics
. Other medications deemed by study team to endanger the health of the participant or unduly confound the results
. Cognitive impairment (Mini-Mental State Examination score \< 20)
. Past or current bipolar disorder or psychotic symptoms according to the DSM-V
. Substance abuse disorder or suicidal ideation within the previous year
. Not able to participate in a supervised exercise program based on the presence of unstable angina, recent MI (within last 3 months), hemiparetic gait, inability to walk at least 1mph on treadmill safely, poorly controlled hypertension (resting blood pressure \> 190/110), peripheral arterial disease with current foot or leg ulcers, or cardiac or pulmonary disease with exercise tolerance NYHA class 3 or higher.
. Active cancer that is currently undergoing treatment (receiving chemotherapy and/or radiation therapy)