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Brain Morphometry in OA Patients Treated With Duloxetine

Primary Purpose

Pain, Osteoarthritis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Duloxetine

Placebo Oral Tablet

About this trial

This is an interventional basic science trial for Pain focused on measuring placebo, pain, osteoarthritis

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Northwestern University Feinberg School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Placebo

Arm Description

placebo capsule

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Overall Brain Neocortical Gray Matter Volume

Full Information

NCT ID

NCT02903238

First Posted

August 26, 2016

Last Updated

January 17, 2017

Sponsor

Northwestern University

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02903238

Brief Title

Brain Morphometry in OA Patients Treated With Duloxetine

Official Title

Brain Morphometric Study in Knee Osteoarthritis Patients Treated With Duloxetine

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Osteoarthritis

Keywords

placebo, pain, osteoarthritis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Experimental

Arm Description

placebo capsule

Intervention Type

Drug

Intervention Name(s)

Duloxetine

Other Intervention Name(s)

Cymbalta

Intervention Description

Duloxetine Delayed-Release Capsules: 30mg/day for 1 week ; 60mg/day for the remaining time

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Tablet

Other Intervention Name(s)

Placebo

Intervention Description

Lactose capsule

Primary Outcome Measure Information:

Title

Brain Regional Gray Matter Density

Description

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

WOMAC Pain Index

Description

Time Frame

2 weeks

Title

Overall Brain Neocortical Gray Matter Volume

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Apkar V Apkarian, PhD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University Feinberg School of Medicine

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The data will be available at http://OpenfMRI.org

Citations:

PubMed Identifier

27788130

Citation

Tetreault P, Mansour A, Vachon-Presseau E, Schnitzer TJ, Apkarian AV, Baliki MN. Brain Connectivity Predicts Placebo Response across Chronic Pain Clinical Trials. PLoS Biol. 2016 Oct 27;14(10):e1002570. doi: 10.1371/journal.pbio.1002570. eCollection 2016 Oct.

Results Reference

derived

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Brain Morphometry in OA Patients Treated With Duloxetine

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