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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline pain severity at 12 weeks
Awards & highlights

Study Summary

This trial will study whether adding duloxetine to aerobic exercise can help treat adults with symptomatic knee osteoarthritis and depression.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hamilton Depression Rating Scale (HAM-D)
Knee Osteoarthritis Outcomes Scale (KOOS) pain subscale
Secondary outcome measures
Maximal oxygen consumption

Side effects data

From 2012 Phase 4 trial • 291 Patients • NCT01118780
11%
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

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

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,672 Previous Clinical Trials
28,018,633 Total Patients Enrolled
29 Trials studying Osteoarthritis
10,028 Patients Enrolled for Osteoarthritis
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,626 Total Patients Enrolled
3 Trials studying Osteoarthritis
118 Patients Enrolled for Osteoarthritis

Media Library

Aerobic exercise Clinical Trial Eligibility Overview. Trial Name: NCT04111627 — Phase 2
Osteoarthritis Clinical Trial 2023: Aerobic exercise Highlights & Side Effects. Trial Name: NCT04111627 — Phase 2
Aerobic exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT04111627 — Phase 2
Osteoarthritis Research Study Groups: Aerobic exercise plus Duloxetine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical issues can be effectively treated with Duloxetine?

"Duloxetine is often prescribed to patients suffering from diabetic peripheral neuropathy (dpn). This medication has also been proven effective in managing knee pain, major depressive disorder (mdd), and issues with the musculoskeletal system."

Answered by AI

Are there still opportunities to join this clinical trial?

"Affirmative. Per the information posted on clinicaltrials.gov, this healthcare study is currently recruiting eligible participants and was initially shared on October 7th 2021. The research team seeks to enroll thirty individuals from a single site for their investigation into the efficacy of this medical intervention."

Answered by AI

Could you shed light on other research conducted using Duloxetine?

"Currently, 22 research trials for Duloxetine are underway with 4 in the critical Phase 3. Redwood City, California is home to a handful of these experiments but there are 781 locations globally participating in clinical trials involving this medication."

Answered by AI

Has the FDA sanctioned Duloxetine for use?

"Duloxetine has been evaluated in Phase 2 clinical trials, showing some evidence to support safety but not efficacy. As such, we have rated its safety as a level 2 on our scale of 1-3."

Answered by AI

How many participants are being monitored as part of this research protocol?

"Affirmative. Per the details published on clinicaltrials.gov, this research trial is currently looking for participants and was originally posted on October 7th 2021; with its most recent update being January 24th 2022. 30 people must be recruited from one medical facility to complete the study's requirements."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
How old are they?
65+
What site did they apply to?
University of Maryland School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Exercise Plus Duloxetine for Knee Osteoarthritis
Alan Rathbun 2021. "Exercise Plus Duloxetine for Knee Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04111627.
All > Depression Baltimore > Knee Osteoarthritis
~4 spots leftby Sep 2024
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