drugset / Trial / NCT04582916

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

NCT04582916

Phase 1 Recruiting 64 enrolled National Institute of Mental Health (NIMH)
NaSingle-groupOpen-labelDiagnostic

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

Timeline

Start
2021-07-20
Primary completion
2029-10-03
Completion
2030-04-11

Drugs

EvaluationDrugModalityDoseRoute
Subject 11C-MCI Unknown Intravenous
Subject 11C-PS13 Diagnostic / imaging agent Intravenous

Indications