Exercise Plus Duloxetine for Knee Osteoarthritis and Depression

• Status: Recruiting
• Trial end date: 2025-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland, Baltimore
• Collaborator: National Institute on Aging (NIA)
• Treatments: Duloxetine Hydrochloride

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 antidepressants, 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