Trial Outcomes & Findings for Brain Morphometry in OA Patients Treated With Duloxetine (NCT NCT02903238)

NCT ID: NCT02903238

Last Updated: 2017-03-07

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2017-03-07

Participant Flow

Participant milestones

Measure	Placebo placebo capsule placebo: lactose containing capsule
Overall Study STARTED	21
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Placebo placebo capsule placebo: lactose containing capsule
Overall Study Lost to Follow-up	4

Baseline Characteristics

Brain Morphometry in OA Patients Treated With Duloxetine

Baseline characteristics by cohort

Measure	Placebo n=17 Participants placebo capsule placebo: lactose containing capsule
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	56.88 years STANDARD_DEVIATION 5.68 • n=5 Participants
Gender Female	9 Participants n=5 Participants
Gender Male	8 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants
Pain (Visual Analogue Score, VAS)	7.03 units on a scale STANDARD_DEVIATION 1.08 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Placebo Responders n=8 Participants placebo capsule placebo: lactose containing capsule	Placebo Non-responders n=9 Participants placebo capsule placebo: lactose containing capsule
Brain Regional Gray Matter Density	0.420 Gray Matter Density: 0 to 1 Standard Deviation 0.083	0.425 Gray Matter Density: 0 to 1 Standard Deviation 0.060

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Placebo Responders n=8 Participants placebo capsule placebo: lactose containing capsule	Placebo Non-responders n=9 Participants placebo capsule placebo: lactose containing capsule
WOMAC Pain Index	38.6 Percent Change in WOMAC score Standard Deviation 24.6	4.6 Percent Change in WOMAC score Standard Deviation 21.3

SECONDARY outcome

Timeframe: 2 weeks

Population: Data were not collected and the Outcome will never be analyzed

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Apkar Vania Apkarian

Northwestern University Medical School

Phone: (312) 503-0404

Email: a-apkarian@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place