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Exercise + Duloxetine for Knee Osteoarthritis
Baltimore, MD
Phase 2
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
40 years or older
Major depressive disorder satisfying diagnostic criteria according to the DSM-V
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline pain severity at 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a treatment combining duloxetine and aerobic exercise for adults with knee osteoarthritis and depression. Duloxetine helps manage pain and mood, making it easier for patients to stick to their exercise routine. Duloxetine, an anti-depressant medication, has been recently approved for managing knee osteoarthritis and has shown effectiveness in reducing pain and improving function in patients with osteoarthritis.
Who is the study for?
This trial is for English-speaking adults over 40 with knee osteoarthritis and depression, who can do aerobic exercise but aren't currently exercising twice a week or more. They shouldn't be planning knee surgery within six months, have cognitive issues, unstable heart conditions, severe hypertension, certain leg diseases, or be pregnant.
What is being tested?
The study tests adding the drug Duloxetine to an aerobic exercise program for treating knee osteoarthritis and depression in adults. Everyone gets both treatments; first checking if it's feasible then doing a pilot test to see how well it works.
What are the potential side effects?
Duloxetine may cause nausea, dry mouth, sleepiness, constipation or fatigue. Aerobic exercise is generally safe but could lead to muscle soreness or joint pain especially when starting new activities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
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I have been diagnosed with major depressive disorder.
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I have been diagnosed with painful knee arthritis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot safely do supervised exercise due to my current health issues.
Select...
I am currently receiving treatment for my active cancer.
Select...
I am currently taking medications like duloxetine, antipsychotics, benzodiazepines, or opioids.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline depression severity at 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline depression severity at 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hamilton Depression Rating Scale (HAM-D)
Knee Osteoarthritis Outcomes Scale (KOOS) pain subscale
Secondary study objectives
Maximal oxygen consumption
Side effects data
From 2012 Phase 4 trial • 291 Patients • NCT0111878011%
Nausea
11%
Headache
9%
Constipation
8%
Dizziness
7%
Dry mouth
6%
Somnolence
5%
Diarrhoea
4%
Abdominal pain upper
4%
Fall
4%
Decreased appetite
4%
Pruritus
3%
Vertigo
3%
Hyperhidrosis
2%
Nasopharyngitis
1%
Hypertensive crisis
1%
Angina pectoris
1%
Back pain
1%
Insomnia
1%
Large intestinal obstruction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Duloxetine
Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Aerobic exercise plus DuloxetineExperimental Treatment2 Interventions
Participants will have a starting duloxetine dosage of 30 mg/day and be titrated up to a daily optimal dosage of 60 mg/day as tolerated during the first 12-weeks of the study. Twelve weeks after the receipt of their prescription, participants will be evaluated for the need to increase medication dosage to 90 mg/day. After duloxetine initiation, participants will be provided an exercise prescription that includes a progressive walking program aiming to achieve 50 minutes of moderate-intensity physical activity, three times per week, over 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic exercise
2000
Completed Phase 2
~1130
Duloxetine
2011
Completed Phase 4
~4170
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Duloxetine, a Serotonin-Norepinephrine Reuptake Inhibitor (SNRI), increases serotonin and norepinephrine levels to modulate pain perception and improve mood, addressing both pain and depressive symptoms in Osteoarthritis (OA) patients. Aerobic exercise enhances muscle strength, flexibility, and overall physical fitness, improving joint function and boosting mood.
Together, these treatments provide a comprehensive approach to managing OA by targeting both physical and psychological aspects of the disease.
Find a Location
Closest Location:University of Maryland School of Medicine· Baltimore, MD
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,802 Previous Clinical Trials
28,193,951 Total Patients Enrolled
33 Trials studying Osteoarthritis
10,425 Patients Enrolled for Osteoarthritis
University of Maryland, BaltimoreLead Sponsor
716 Previous Clinical Trials
381,084 Total Patients Enrolled
3 Trials studying Osteoarthritis
118 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot safely do supervised exercise due to my current health issues.I am 40 years old or older.I have been diagnosed with major depressive disorder.I do not plan to have knee surgery for osteoarthritis in the next 6 months.I am currently receiving treatment for my active cancer.I have been diagnosed with painful knee arthritis.I am currently taking medications like duloxetine, antipsychotics, benzodiazepines, or opioids.My current medications won't interfere with the study.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Aerobic exercise plus Duloxetine