Duloxetine in Osteoarthritis (OA) Pain
Brain Morphometries in OA Patients Treated With Duloxetine
1 other identifier
interventional
40
1 country
1
Brief Summary
This study aims to determine in people with knee Osteoarthritis (OA) if relief of pain after treatment with either duloxetine or placebo is associated with changes in brain anatomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 16, 2012
CompletedFirst Posted
Study publicly available on registry
March 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
December 29, 2014
CompletedDecember 29, 2014
December 1, 2014
2.1 years
March 16, 2012
December 5, 2014
December 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Brain Gray Matter Volume
The change in gray matter volume is evaluated by subtracting the volume after the treatment (week 16) to the volume before treatment (baseline)
16 weeks compared to baseline
Secondary Outcomes (1)
Change in Pain Magnitude
16 weeks compared to baseline
Study Arms (2)
Duloxetine
EXPERIMENTALDuloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.
Sugar pill
PLACEBO COMPARATORMatching capsule given once a day for a total of 17 weeks.
Interventions
Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.
Matching capsule given once a day for a total of 17 weeks.
Eligibility Criteria
You may qualify if:
- Age: 45-80 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, depression
- 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
- Use of MAO inhibitors, triptans, serotonin precursors (tryptophan)
- Use of potent CYP1A2 inhibitors, Thioridazine, and anti-depressants
- 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
- Metal fragments in the eye or face, or having worked previously in the metal industry
- Implantation of any electronic devices such as (but not limited to) cardiac pacemakers, cardiac, defibrillators, and cochlear implants or nerve stimulators.
- Surgery on the blood vessels of the brain
- Claustrophobia (fear of enclosed places)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- Eli Lilly and Companycollaborator
Study Sites (1)
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Related Publications (2)
Leaney AA, Lyttle JR, Segan J, Urquhart DM, Cicuttini FM, Chou L, Wluka AE. Antidepressants for hip and knee osteoarthritis. Cochrane Database Syst Rev. 2022 Oct 21;10(10):CD012157. doi: 10.1002/14651858.CD012157.pub2.
PMID: 36269595DERIVEDTetreault 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: 27788130DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Apkar Vania Apkarian
- Organization
- Northwestern University
Study Officials
- STUDY DIRECTOR
Thomas Schnitzer, MD, PhD
Northwestern University Feinberg School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 16, 2012
First Posted
March 20, 2012
Study Start
March 1, 2012
Primary Completion
April 1, 2014
Study Completion
August 1, 2014
Last Updated
December 29, 2014
Results First Posted
December 29, 2014
Record last verified: 2014-12