Combining exercise with duloxetine for knee osteoarthritis and depression
A Feasibility and Pilot Study of Combined Treatment Protocol Using Aerobic Exercise and Duloxetine in Older Adults With Symptomatic Knee Osteoarthritis and Comorbid Depression
This study is testing whether combining an antidepressant called duloxetine with an exercise program can help adults with knee osteoarthritis and depression feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04111627 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of adding duloxetine, an antidepressant, to an aerobic exercise program for adults suffering from knee osteoarthritis and depressive symptoms. The research aims to enhance treatment adherence by addressing both physical and mental health challenges simultaneously. Participants will engage in a supervised exercise regimen while receiving duloxetine, with the study first assessing the feasibility of this combined approach before conducting a pilot test. This innovative protocol seeks to improve overall patient outcomes by targeting the co-occurrence of knee pain and depression.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 40 and older with symptomatic knee osteoarthritis and major depressive disorder.
Not a fit: Patients who are already engaged in regular aerobic exercise or those with certain psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and mental health for patients with knee osteoarthritis and depression.
How similar studies have performed: While there have been studies on exercise and depression, this specific combination of aerobic exercise and duloxetine for knee osteoarthritis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. English speaking 2. 40 years or older 3. Symptomatic knee osteoarthritis fulfilling 1986 American College of Rheumatology criteria 4. No plan for surgical knee osteoarthritis intervention within six months of enrollment 5. Major depressive disorder satisfying diagnostic criteria according to the DSM-V 6. Ability to participate in a supervised aerobic exercise program Exclusion Criteria: 1. Already performing aerobic or resistive exercise 2x/week or more 2. Taking duloxetine, antipsychotics, benzodiazepines, or opioid analgesics 3. Other medications deemed by study team to endanger the health of the participant or unduly confound the results 4. Cognitive impairment (Mini-Mental State Examination score \< 20) 5. Past or current bipolar disorder or psychotic symptoms according to the DSM-V 6. Substance abuse disorder or suicidal ideation within the previous year 7. 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. 8. Active cancer that is currently undergoing treatment (receiving chemotherapy and/or radiation therapy) 9. Pregnant or lactating women 10. Other conditions deemed by study team to endanger the health of the participant or unduly confound the results
Where this trial is running
Baltimore, Maryland
- University of Maryland School of Medicine — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: Alan M Rathbun, PhD, MPH
- Email: arathbun@som.umaryland.edu
- Phone: 410-706-5151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.