Exercise Plus Duloxetine for Knee Osteoarthritis

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Symptomatic knee osteoarthritis (OA) affects 10% of men and 13% of women 60 years or older, and depressive symptoms are common, occurring in one-fifth of these patients. Depressive symptoms worsen knee OA disease severity and are a barrier to pain management and engagement in physical activity. Guidelines recommend depression treatment in older adults with knee OA but provide no direction on how to simultaneously manage the co-occurrence of physical and mental morbidity. Treatment recommendations advise exercise to manage pain and disability and improve psychosocial health in knee OA patients; however, compliance to exercise programs is low in persons with chronic pain and disability and is only made worse by comorbid depression. Adherence is critical to the efficacy of depression treatments using exercise training, and no such exercise program has ever been designed for and tested in OA patients with co-occurring depressive symptoms in a way to enhance compliance. Duloxetine is the only antidepressant medication indicated for pain management in knee OA patients that has demonstrated efficacy and tolerability when treating depression in older adults and is a viable pharmacological complement to exercise. There are no protocols that combine treatments using interventions that affect symptoms of both knee OA and depression, and the study goals are to evaluate the feasibility of and then pilot test a protocol comprised of aerobic exercise training plus duloxetine for the treatment of symptomatic knee OA and comorbid depression. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04111627
Study type	Interventional
Source	University of Maryland, Baltimore
Contact	Alan M Rathbun, PhD, MPH
Phone	410-706-5151
Email	arathbun@som.umaryland.edu
Status	Recruiting
Phase	Phase 2
Start date	October 7, 2021
Completion date	December 30, 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05777044` - The Effect of Hatha Yoga on Mental Health	N/A
Recruiting	`NCT04977232` - Adjunctive Game Intervention for Anhedonia in MDD Patients	N/A
Recruiting	`NCT04680611` - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting	`NCT04043052` - Mobile Technologies and Post-stroke Depression	N/A
Completed	`NCT04512768` - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy	N/A
Recruiting	`NCT03207828` - Testing Interventions for Patients With Fibromyalgia and Depression	N/A
Completed	`NCT04617015` - Defining and Treating Depression-related Asthma	Early Phase 1
Recruiting	`NCT06011681` - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed	`NCT04476446` - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives	Phase 3
Recruiting	`NCT02783430` - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease	Phase 2/Phase 3
Recruiting	`NCT05563805` - Exploring Virtual Reality Adventure Training Exergaming	N/A
Completed	`NCT04598165` - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support	N/A
Completed	`NCT03457714` - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting	`NCT05956912` - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed	`NCT05588622` - Meru Health Program for Cancer Patients With Depression and Anxiety	N/A
Recruiting	`NCT05234476` - Behavioral Activation Plus Savoring for University Students	N/A
Active, not recruiting	`NCT05006976` - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study	N/A
Enrolling by invitation	`NCT03276585` - Night in Japan Home Sleep Monitoring Study
Terminated	`NCT03275571` - HIV, Computerized Depression Therapy & Cognition	N/A
Completed	`NCT03167372` - Pilot Comparison of N-of-1 Trials of Light Therapy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.