Brain Morphometry in OA Patients Treated With Duloxetine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02903238|
Recruitment Status : Completed
First Posted : September 16, 2016
Results First Posted : March 7, 2017
Last Update Posted : March 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain Osteoarthritis||Drug: Duloxetine Drug: Placebo Oral Tablet||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Brain Morphometric Study in Knee Osteoarthritis Patients Treated With Duloxetine|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||December 2011|
Duloxetine Delayed-Release Capsules: 30mg/day for 1 week ; 60mg/day for the remaining time
Other Name: Cymbalta
Drug: Placebo Oral Tablet
Other Name: Placebo
- Brain Regional Gray Matter Density [ Time Frame: 2 weeks ]
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.
- WOMAC Pain Index [ Time Frame: 2 weeks ]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).
- Overall Brain Neocortical Gray Matter Volume [ Time Frame: 2 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02903238
|United States, Illinois|
|Northwestern University Feinberg School of Medicine|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Apkar V Apkarian, PhD||Northwestern University|