Brain Morphometry in OA Patients Treated With Duloxetine

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02903238
• Collaborator: Eli Lilly and Company (Industry)
• Enrollment: 21
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 4.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Osteoarthritis	Drug: Duloxetine; Drug: Placebo Oral Tablet	N/A

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

• Study Type: Interventional
• 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: Jul 1, 2011
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

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 Names: Cymbalta ; Drug: Placebo Oral Tablet; Lactose capsule; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. Brain Regional Gray Matter Density [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 [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 [2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University
• Eli Lilly and Company

Investigators

• Principal Investigator: Apkar V Apkarian, PhD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Apkar Apkarian, Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT02903238
• Other Study ID Numbers: STU00039556A
• First Posted: Sep 16, 2016
• Last Update Posted: Mar 7, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Apkar Apkarian, Professor, Northwestern University: placebo; pain; osteoarthritis
• Additional relevant MeSH terms: Osteoarthritis; Duloxetine Hydrochloride

Study Results

Participant Flow

Arm/Group Title	Placebo
Arm/Group Description	placebo capsule placebo: lactose containing capsule
Period Title: Overall Study
STARTED	21
COMPLETED	17
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Placebo
Arm/Group Description	placebo capsule placebo: lactose containing capsule
Overall Participants	17
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	15 88.2%
>=65 years	2 11.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.88 (5.68)
Gender (Count of Participants)
Female	9 52.9%
Male	8 47.1%
Region of Enrollment (participants) [Number]
United States	17 100%
Pain (Visual Analogue Score, VAS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	7.03 (1.08)

Outcome Measures

1. Primary Outcome

Title	Brain Regional Gray Matter Density
Description	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.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Responders	Placebo Non-responders
Arm/Group Description	placebo capsule placebo: lactose containing capsule	placebo capsule placebo: lactose containing capsule
Measure Participants	8	9
Mean (Standard Deviation) [Gray Matter Density: 0 to 1]	0.420 (0.083)	0.425 (0.060)

2. Secondary Outcome

Title	WOMAC Pain Index
Description	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).
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Responders	Placebo Non-responders
Arm/Group Description	placebo capsule placebo: lactose containing capsule	placebo capsule placebo: lactose containing capsule
Measure Participants	8	9
Mean (Standard Deviation) [Percent Change in WOMAC score]	38.6 (24.6)	4.6 (21.3)

3. Secondary Outcome

Title	Overall Brain Neocortical Gray Matter Volume
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Data were not collected and the Outcome will never be analyzed

Arm/Group Title	Placebo Responders	Placebo Non-responders
Arm/Group Description	placebo capsule placebo: lactose containing capsule	placebo capsule placebo: lactose containing capsule
Measure Participants	0	0

Adverse Events

Time Frame	2 weeks
Arm/Group Title	Placebo
Arm/Group Description	placebo capsule placebo: lactose containing capsule
All Cause Mortality
	Placebo
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Placebo
	Affected / at Risk (%)	# Events
Total	0/17 (0%)
Other (Not Including Serious) Adverse Events
	Placebo
	Affected / at Risk (%)	# Events
Total	0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.