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Brain Morphometry in OA Patients Treated With Duloxetine

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ClinicalTrials.gov Identifier: NCT02903238
Recruitment Status : Completed
First Posted : September 16, 2016
Results First Posted : March 7, 2017
Last Update Posted : March 7, 2017
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Apkar Apkarian, Northwestern University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Osteoarthritis Drug: Duloxetine Drug: Placebo Oral Tablet Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Placebo
placebo capsule
 Drug: Duloxetine
Duloxetine Delayed-Release Capsules: 30mg/day for 1 week ; 60mg/day for the remaining time
Other Name: Cymbalta

Drug: Placebo Oral Tablet
Lactose capsule
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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).

  2. Overall Brain Neocortical Gray Matter Volume [ Time Frame: 2 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Eli Lilly and Company
Investigators
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Principal Investigator: Apkar V Apkarian, PhD Northwestern University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Apkar Apkarian, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02903238    
Other Study ID Numbers: STU00039556A
First Posted: September 16, 2016    Key Record Dates
Results First Posted: March 7, 2017
Last Update Posted: March 7, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be available at http://OpenfMRI.org
Keywords provided by Apkar Apkarian, Northwestern University:
placebo
pain
osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents