Brain Morphometry in OA Patients Treated With Duloxetine

NCT02903238 | Completed Results

• 1 other identifier: STU00039556A
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Osteoarthritis

Keywords

placebo; pain; osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Secondary Outcomes (2)

• WOMAC Pain Index

  2 weeks

• Overall Brain Neocortical Gray Matter Volume

  2 weeks

Study Arms (1)

Placebo

EXPERIMENTAL

placebo capsule

Drug: Duloxetine; Drug: Placebo Oral Tablet

Interventions

Duloxetine DRUG

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

Also known as: Cymbalta

Placebo

Placebo Oral Tablet DRUG

Lactose capsule

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 27788130 DERIVED

MeSH Terms

Conditions

Pain; Osteoarthritis

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Apkar Vania Apkarian
• Organization: Northwestern University Medical School

a-apkarian@northwestern.edu

(312) 503-0404

Study Officials

• Apkar V Apkarian, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 16, 2016
• Study Start: July 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 7, 2017
• Results First Posted: March 7, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)