18FPF-06445974 to Image PDE4B in Major Depressive Disorder Using PET

What this Trial Is About

Researchers are studying major depressive disorder MDD, a mental health condition marked by episodes of depression called major depressive episodes MDEs. The study aims to find out if levels of an enzyme called PDE4B are lower in the brains of people experiencing an MDE. It also seeks to determine the best scanning time using a radioactive tracer called 18FPF-06445974, how reliable the scans are, and whether PDE4B levels relate to clinical symptoms. The study also tests if PDE4B binding in the brain can be blocked by the drug apremilast. Participants will undergo up to five clinic visits including screening, physical exams, blood tests, heart function tests, psychiatric assessments, and brain imaging. Brain imaging includes MRI scans and PET scans where the tracer 18FPF-06445974 is injected intravenously. The PET scan lasts up to four hours with a break. Some participants may have a second PET scan, a lung scan, or receive oral apremilast. Monitoring of heart rate, blood pressure, breathing, and blood sampling during scans is included. During the study, participants answer questions about their mental state and undergo clinical rating scales. Researchers measure PDE4B levels in the brain and assess how these relate to symptoms. Safety monitoring includes checking medical history, ECG, labs, and ability to tolerate scans. The main outcome is measuring PDE4B distribution volume over 36 months. Participants usual care continues throughout, and healthy volunteers are also included for comparison.

[18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET