RecruitingPhase 1NCT05703685

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

Sponsor

National Institute of Mental Health (NIMH)

Enrollment

108 participants

Start Date

Jun 22, 2023

Study Type

INTERVENTIONAL

Conditions

Depression

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

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special type of brain scan called a PET scan with a new imaging agent to visualize a brain protein called PDE4B, which may play a role in major depressive disorder. Researchers are comparing PDE4B levels in people with depression versus healthy volunteers to better understand the biology of depression. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with major depressive disorder (MDD) and are currently experiencing a depressive episode lasting at least 4 weeks - Your depression score is above the required threshold on standardized scales - You are in generally good health beyond your depression - You have a primary care physician or psychiatrist in the community **You may NOT be eligible if...** - You have psychotic symptoms, bipolar disorder, or another serious psychiatric diagnosis - You are currently pregnant or breastfeeding - You have significant metal implants or other contraindications to the study procedures - You are not willing to follow study lifestyle requirements 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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