Celecoxib's effect on inflammation in major depressive disorder
The Effect of Celecoxib on Neuroinflammation in MDD: PET Imaging of a Novel Treatment Target with [18F]FEPPA
This study is testing whether the anti-inflammatory medication celecoxib can help people with major depressive disorder feel better, especially those who haven't found relief from regular antidepressants.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Stony Brook University Academic / other |
| Locations | 1 site (Stony Brook, New York) |
| Trial ID | NCT04814355 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of celecoxib, an anti-inflammatory medication, on neuroinflammation in patients diagnosed with major depressive disorder (MDD). The study aims to explore whether reducing neuroinflammation can improve depressive symptoms, particularly in individuals who do not respond to traditional antidepressant therapies. Participants will be assessed using positron emission tomography (PET) imaging to measure neuroinflammation levels before and after treatment with celecoxib. The trial focuses on patients currently experiencing a major depressive episode and evaluates the medication's safety and efficacy in this context.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 who have been diagnosed with major depressive disorder and are currently experiencing a major depressive episode.
Not a fit: Patients with contraindications to celecoxib or those currently taking medications that interact with it may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with major depressive disorder who do not respond to existing therapies.
How similar studies have performed: Other studies have indicated a potential link between neuroinflammation and depression, suggesting that anti-inflammatory treatments like celecoxib may offer new avenues for effective management of MDD.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stony Brook, New York
- Psychiatry Department at Stony Brook University — Stony Brook, New York, United States (Recruiting)
Study contacts
- Principal investigator: Christine DeLorenzo, PhD — Stony Brook University
- Study coordinator: Alexandra Checkers, MBA
- Email: alexandra.checkers@stonybrookmedicine.edu
- Phone: 631-638-0291
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.