Brain Morphometry in OA Patients Treated With Duloxetine

Study Overview
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Brief Summary
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This is a two week,single-blind study evaluating pain response and changes in brain imaging upon treatment with placebo in people with knee OA.

Detailed Description
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In this study, all the participants will be receiving placebo. However this study will be single blinded in that participants will be told that they will be given a pill that may or may not help with their pain. The researcher, however, will know that all participants are receiving placebo At the initial visit, participants will undergo screening to determine that they meet all inclusion and exclusion criteria. They will sign consent and then complete pain assessment instruments as well as one high resolution anatomical scan (T1) and one functional scan (a resting scar) in a 3 Tesla magnet. A single scanning session comprised of a 10 minute functional scan (a resting scan) will be done two weeks from the first scan and pain assessment instruments will be completed at this visit as well. After finishing this second scan (done two weeks after the initial scan), the participants will have completed the study.

Official Title
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Brain Morphometric Study in Knee Osteoarthritis Patients Treated With Duloxetine

Conditions
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Pain, Osteoarthritis

Intervention / Treatment
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* Drug: Duloxetine
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 40-85 years ACR criteria for OA including Kellgren-Lawrence radiographic OA grades II-IV VAS pain score >5/10 within 48 hrs of the phone screen and visit 1 (Screening) Knee OA for a minimum of 12 months Need for daily pain medication to manage symptoms of OA Exclusion Criteria: Currently taking MAO inhibitors or any centrally acting drug for analgesia Narrow angle glaucoma Uncontrolled hypertension Co-existing inflammatory arthritis, fibromyalgia or other chronic pain state If a female, pregnant, trying to become pregnant, or lactating Major depressive disorder Substantial alcohol use or history of significant liver disease Diabetes, type 1 or type 2 Condition in which the Investigator believes would interfere with the subject's ability to comply with study instructions, or might confound the interpretation of the study results or put the subject at undue risk Standard MRI safety exclusions

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo<br>placebo capsule | Drug: Duloxetine<br>* Duloxetine Delayed-Release Capsules: 30mg/day for 1 week ; 60mg/day for the remaining time<br>* Other names: Cymbalta;Drug: Placebo Oral Tablet<br>* Lactose capsule<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain Regional Gray Matter Density | Gray matter density (GMD) of the prefrontal cortex region identified as placebo biomarker. Placebo responders/non-responders were identified based on the VAS score. A minimum of 20% decrease in VAS score was needed to be qualified as responders. GMD is a value between 0 and 1 representing the intensity of every brain voxels. The GMD of the prefrontal cortex region represent the average GMD of every voxels in this region. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC Pain Index | Osteoarthritis (OA) specific pain and quality of life index (the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC). The WOMAC score is from 0 to 96 where 0 represent no pain and quality of life impairment due to OA and 96 represent the worst pain and quality of life impairment due to OA. The outcome is reported as the percent change from baseline to end of treatment (2 weeks). | 2 weeks | 
| Overall Brain Neocortical Gray Matter Volume |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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placebo, pain, osteoarthritis