Imaging PDE4B Levels in Adults with Major Depressive Disorder Using PET Scans with 18FPF-06445974

What this Trial Is About

Researchers are investigating whether the enzyme phosphodiesterase 4B PDE4B is reduced in the brains of people with major depressive disorder MDD experiencing a major depressive episode MDE. This study will also explore how well a new radioactive tracer, 18FPF-06445974, can measure PDE4B in the brain, including the best scan length and reliability, as well as how PDE4B levels relate to clinical rating scales. Additionally, the study will assess if PDE4B binding can be blocked by the drug apremilast. Participants will undergo up to five clinic visits including screening, physical exams, blood tests, and heart function tests. Imaging involves MRI scans followed by PET scans where the radioactive tracer is injected intravenously through a catheter. During the PET scan, participants will be monitored closely, including blood pressure and heart rate, and blood samples will be collected via a wrist artery catheter. Some participants may have a second PET scan, a lung scan immediately after the brain scan, or receive oral apremilast to evaluate PDE4B blocking. Throughout the study, participants will complete psychiatric assessments and questionnaires about their mental state. Researchers will measure PDE4B distribution volume in the brain and examine its correlation with clinical symptoms. Safety monitoring includes vital signs before, during, and after PET scanning. The study aims to complete within several years, with the primary outcome focused on measuring PDE4B density and related scan parameters to better understand MDD.

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