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18F-PF-06445974 / Depression / Lung scan · Phase 1 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 imaging study registered with NIMH to evaluate whether the PDE4B enzyme is reduced in the brains of people with major depressive disorder during a depressive episode, using a novel PET radiotracer [18F]PF-06445974. No results are currently available; the study is actively recruiting and remains at an exploratory, mechanistic stage.
Phase 1, Interventional, Single Group, Open label, Diagnostic purpose. Depression; age from 18 Years; to 70 Years; accepts healthy volunteers. Intervention: one arm. Compared with: Healthy volunteers (control group comparison implied).. n = 108. 1 site: United States.
This is a Phase 1 imaging study registered with NIMH to evaluate whether the PDE4B enzyme is reduced in the brains of people with major depressive disorder during a depressive episode, using a novel PET radiotracer [18F]PF-06445974. No results are currently available; the study is actively recruiting and remains at an exploratory, mechanistic stage.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This study does not yet provide evidence to guide clinical practice. Once complete, results would inform whether PDE4B is a viable biomarker or therapeutic target in MDD, potentially supporting development of PDE4B-targeted interventions.
This is a Phase 1 mechanistic imaging study in active recruitment with no results posted; it aims to establish whether PDE4B is reduced in MDD brains using a novel radioligand, representing early-phase exploratory work.
As stated by the source record.
Quoted from the source exactly as published.
This study does not yet provide evidence to guide clinical practice. Once complete, results would inform whether PDE4B is a viable biomarker or therapeutic target in MDD, potentially supporting development of PDE4B-targeted interventions.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05703685). This is a study registration, not published results. Lead sponsor: National Institute of Mental Health (NIMH). Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 108 participants (ESTIMATED). Conditions: Depression. Interventions: RADIATION: Lung scan; DRUG: Apremilast; DRUG: 18F-PF-06445974. Primary outcome measures: To measure distribution volume , 36 months. Brief summary: Background: Major depressive disorder (MDD) is a psychiatric condition. People with MDD have occasional bouts of depressive symptoms; these bouts are called major depressive episodes (MDEs). Researchers want to know if people having MDEs have lower levels of an enzyme called PDE4B in their brains. Primary Objective: To determine whether PDE4B is reduced in the brains of individuals with MDD experiencing a major depressive episode (MDE). Secondary Objectives: To determine the optimal length of scanning and the retest variability and reliability of \[18F\]PF-06445974, and whether PDE4B binding correlates with clinical rating scales. To measure if PDE4B radioligand binding can be blocked by taking apremilast. Eligibility: People aged 18-70 years with MDD. Healthy volunteers are also needed. Design: Participants will have up to 5 clinic visits. Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. Some participants may have a psychiatric assessment; they will answer questions about their state of mind and related topics. Participants will have magnetic resonance imaging (MRI) of the brain. They will lie on a table that slides into a metal cylinder. Participants will have a positron emission tomography (PET) scan. A needle will be used to guide a thin plastic tube (catheter) into a vein in one arm. An experimental substance called a radioactive tracer (\[18F\]PF-06445974) will be injected through the catheter. Participants will lie on a table that slides into a doughnut-shaped machine. The scan will last up to 4 hours with a 15-minute break. Participants blood pressure, heart rate, and breathing will be monitored before, during, and after the PET scan. A second catheter will be inserted in the artery of the wrist so blood can be drawn during the scan. Some participants may return for a second PET scan; have a lung scan or receive apremilast. https://nimhcontent.nimh.nih.gov/start/surveys/?s=KE88DXXPLDFHHTF8
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.