Status:
ACTIVE_NOT_RECRUITING
The Effect of Celecoxib on Neuroinflammation in MDD
Lead Sponsor:
Stony Brook University
Collaborating Sponsors:
Brain & Behavior Research Foundation
Conditions:
Major Depressive Disorder
Neuroinflammation
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Major depressive disorder (MDD) affects an estimated 350 million people worldwide and is a leading contributor to global disease burden. Commonly used monoamine reuptake-inhibiting treatments for depr...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age: 18-65
- Diagnosis of MDD and currently in a major depressive episode
- Capacity to give informed consent
- Score of at least 29 on the MADRS
- Exclusion Criteria
- Low affinity binders (LABs) for TSPO Genotype
- Hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or any component of the formulation; previous asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Heptic impairment, heart failure, severe renal impairment, recent GI bleed, history of peptic ulcer disease, anemia or any other contraindication for celecoxib
- Poor CYP2C9 metabolizer
- Currently taking medications that interact with celecoxib (digoxin, antihypertensives, diuretics, anticoagulant or anti-platelet treatment, including aspirin)
- Use of herbs, drugs, or medications with anti-inflammatory or immunomodulatory properties (within 5 half-lives of starting celecoxib treatment)
- Unlikely to tolerate medication washout or the medication-free period following washout
- Participant considered at significant risk for suicide
- ECT within 1 month
- High potential for excessive drug/alcohol use during the treatment period (excluding nicotine or cannabis)
- Significant active physical illness or neurological deficit that may affect brain functioning or imaging
- Any PET contraindications, including if study imaging will result in the participant receiving greater exposure than the research limit, or if participant is currently pregnant, breastfeeding, or planning to conceive during the course of study participation
Exclusion
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04814355
Start Date
August 1 2018
End Date
February 1 2026
Last Update
August 29 2025
Active Locations (1)
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1
Psychiatry Department at Stony Brook University
Stony Brook, New York, United States, 11794-8101