Actively Recruiting
PET Imaging of Cyclooxygenase in Participants With Major Depressive Disorder (MDD)
Led by National Institute of Mental Health (NIMH) · Updated on 2026-03-13
64
Participants Needed
1
Research Sites
455 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Researchers developed \[11C\]MC1, a radioligand for cyclooxygenase-2 (COX-2). COX-2 is an enzyme induced in the brain during inflammation. Researchers want to see the levels of COX-1 (measured as distribution volume VT) are elevated in the brain of two groups of mood disorders patients undergoing MDE relative to the control group. Objective: To determine whether COX-1 and COX-2 are detectable in the brains of individuals with MDD experiencing a major depressive episode (MDE). Eligibility: People aged 18-70 years with MDD and Healthy Volunteers aged 18 70 years. Design: Group A: MDD participants will be studied with the same dose of \[11C\]MC1 before and after administration of 600 mg celecoxib; the study is neither randomized nor placebo-controlled. Group B: MDD participants, both medicated and unmedicated, will be studied with \[11C\]PS13 and compared to healthy volunteers.. https://nimhcontent.nimh.nih.gov/start/surveys/?s=TJW4RA4WN3LDD988
CONDITIONS
Official Title
PET Imaging of Cyclooxygenase in Participants With Major Depressive Disorder (MDD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 70 years old
- Female participants of childbearing potential must use medically acceptable contraception
- Participants must be in good general health based on medical history and physical exam
- Participants must have sufficient understanding to consent and complete required tests
- All participants must have completed screening assessment under specified protocols
- MDD participants must meet DSM-5 criteria for major depression without psychotic features
- MDD participants must have a MADRS score ≥18 or HAM-D score ≥15 within one week of study entry
- MDD participants must be experiencing a major depressive episode lasting at least four weeks
- Unmedicated participants must be medication-free for at least two weeks (five weeks for aripiprazole, brexpiprazole, fluoxetine) before screening
- Participants must have adequate ulnar collateral flow checked at the radial artery pulse and no metal or foreign objects in both wrists
- Participants must agree to lifestyle considerations
- Healthy controls aged 18 to 70 years old
- Healthy controls must be in good general health without cognitive impairment
- Healthy controls must be enrolled in specified protocols
- Healthy controls must have adequate ulnar collateral flow and no metal or foreign objects in both wrists
- Healthy controls must agree to lifestyle considerations
You will not qualify if you...
- Clinically significant abnormalities on EKG or lab tests, including CBC and metabolic panels
- Creatinine level greater than 1.3 mg/dL
- Use of prohibited medications within required washout periods, including antidepressants, anti-inflammatory drugs (except celecoxib), antipsychotics, anxiolytics, psychotropic drugs, sedatives, or hypnotics
- Use of NSAIDs within two weeks prior to PET scan and aspirin, corticosteroids (except topical), or immunosuppressants within one month
- Current psychotic features or diagnosis of schizophrenia or other psychotic disorders
- History of substance use disorder (except caffeine or nicotine) within the past three months
- Serious suicidal or homicidal risk as judged by investigator
- History of aggressive behavior
- Unstable medical conditions making participation unsafe
- Seeking or changing treatment during study
- Inability to travel to NIH
- Recent excess radiation exposure from other research
- Inability to lie flat and still for at least two hours due to claustrophobia, weight, or behavioral symptoms
- Inability to undergo MRI due to implanted devices or metal fragments
- Pregnancy or breastfeeding
- HIV infection
- NIMH staff or NIH employees related to investigators
- Non-English speaking participants due to neuropsychological testing requirements
- Children excluded due to radiation risk
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
T
Tara N Turon, C.R.N.P.
CONTACT
R
Robert B Innis, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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