Brain Morphometry in OA Patients Treated With Duloxetine

NCT ID: NCT02903238

Last Updated: 2017-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2011-12-31

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.

Conditions

Pain; Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Placebo

placebo capsule

Group Type: EXPERIMENTAL

Duloxetine

Intervention Type: DRUG

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

Placebo Oral Tablet

Intervention Type: DRUG

Lactose capsule

Interventions

Duloxetine

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

Intervention Type: DRUG

Placebo Oral Tablet

Lactose capsule

Intervention Type: DRUG

Other Intervention Names

Cymbalta; Placebo

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Apkar Apkarian

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Apkar V Apkarian, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27788130 (View on PubMed)

Other Identifiers

STU00039556A

Identifier Type: -

Identifier Source: org_study_id