What side effects are associated with this type of intervention?

Duloxetine, an SNRI, is commonly used to manage pain and depression in osteoarthritis patients. Known side effects include nausea, dry mouth, fatigue, constipation, and dizziness. Aerobic exercise, while generally safe and beneficial for improving joint function and mood, can sometimes lead to muscle soreness, joint pain, or injury if not performed correctly. NSAIDs, another common treatment, can cause gastrointestinal issues, cardiovascular risks, and kidney problems. Physical therapy is typically safe but may cause temporary discomfort or pain during or after sessions.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis, focusing on both pharmacologic and non-pharmacologic approaches. Pharmacologic treatments include nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, and diclofenac, which are effective for pain relief. Duloxetine, an SNRI, has also been studied for its dual role in managing pain and depressive symptoms in osteoarthritis patients. Non-pharmacologic treatments like aerobic exercise are recommended to improve joint function and overall mood. These combined approaches aim to provide comprehensive management of osteoarthritis symptoms.

What other types of research exist?

Promising novel alternatives for osteoarthritis treatment in 2024 include: 1) Biologic therapies such as anti-NGF (nerve growth factor) antibodies like tanezumab, which have shown efficacy in reducing pain and improving function in OA patients. 2) Intra-articular injections of platelet-rich plasma (PRP) or stem cell therapy, which aim to promote joint repair and reduce inflammation. 3) Novel small molecule inhibitors targeting specific inflammatory pathways, such as JAK inhibitors. 4) Advanced physical therapy techniques, including the use of wearable technology for personalized exercise regimens and real-time feedback.

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Exercise + Duloxetine for Knee Osteoarthritis

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

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 below

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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:

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I cannot safely do supervised exercise due to my current health issues.

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I am currently receiving treatment for my active cancer.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline depression severity at 12 weeks for reporting.

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 • NCT01118780

11%

Nausea

11%

Headache

Constipation

Dizziness

Dry mouth

Somnolence

Diarrhoea

Abdominal pain upper

Fall

Decreased appetite

Pruritus

Vertigo

Hyperhidrosis

Nasopharyngitis

Hypertensive crisis

Angina pectoris

Back pain

Insomnia

Large intestinal obstruction

100%

80%

60%

40%

20%

Study treatment Arm

Duloxetine

Placebo

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

0 / 6Eligibility criteria met

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.