Status:
COMPLETED
Exercise Plus Duloxetine for Knee Osteoarthritis
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Knee Osteoarthritis
Depression
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Symptomatic knee osteoarthritis (OA) affects 10% of men and 13% of women 60 years or older, and depressive symptoms are common, occurring in one-fifth of these patients. Depressive symptoms worsen kne...
Eligibility Criteria
Inclusion
- 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
- 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)
- Pregnant or lactating women
- Other conditions deemed by study team to endanger the health of the participant or unduly confound the results
Key Trial Info
Start Date :
October 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2025
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04111627
Start Date
October 7 2021
End Date
August 11 2025
Last Update
October 7 2025
Active Locations (1)
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1
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201