RecruitingPhase 1NCT04582916

PET Imaging of Cyclooxygenase in Participants With Major Depressive Disorder (MDD)

Sponsor

National Institute of Mental Health (NIMH)

Enrollment

64 participants

Start Date

Jul 20, 2021

Study Type

INTERVENTIONAL

Conditions

Depression

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study uses special PET brain scans to measure an enzyme called cyclooxygenase (COX) in the brains of people with major depressive disorder (MDD). COX is linked to brain inflammation, and researchers want to understand if inflammation plays a role in depression and how it responds to treatment. **You may be eligible if...** - You are 18–70 years old - You have been diagnosed with major depressive disorder without psychotic symptoms - Your depression score is moderate-to-severe at the time of enrollment - You have been experiencing a depressive episode for at least 4 weeks - You have already been evaluated under a related NIH protocol - If you are taking medications, you have been off them (or on a stable regimen as defined) for at least 2 weeks before scans **You may NOT be eligible if...** - You have a history of psychosis or bipolar disorder - You have active substance abuse (other than caffeine) - You are pregnant or breastfeeding - You have certain physical health conditions that make the procedure unsafe - You have metal objects in your wrists that could be unsafe during blood draws (required for the scan) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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