Depression Clinical Trial
Official title:
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 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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 30, 2025 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland School of Medicine | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knee Osteoarthritis Outcomes Scale (KOOS) pain subscale | The self-reported KOOS pain subscale is sensitive to changes in knee OA symptoms, and consists of nine items scored on a Likert scale (0 [No problems] to 4 [Extreme Problems]) that ranges from 0-36, with higher values indicating greater severity. | Change from Baseline Pain Severity at 12 weeks | |
Primary | Hamilton Depression Rating Scale (HAM-D) | The HAM-D is clinician-administered, 21-item questionnaire, designed to rate the severity of depression in patients. Individual scores are based on the first 17 items, each with a possible score of 0-4 (0=Absent; 4=Extreme Symptoms) or 0-2 (0=Absent; 2=Frequent), yielding an overall range of 0-54. Higher scores indicate greater depression severity. | Change from Baseline Depression Severity at 12 weeks |
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