Actively Recruiting
[18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET
Led by National Institute of Mental Health (NIMH) · Updated on 2026-04-24
108
Participants Needed
1
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
[18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Female participants of childbearing potential must use medically acceptable contraception
- Be in good general health, with stable medical conditions allowed
- Ability to understand and consent to all required tests and procedures
- Completion of a screening assessment under specified protocols
- Meet DSM-5 criteria for major depressive disorder without psychotic features
- Initial depression rating score of MADRS ≥ 18 or HAM-D ≥ 15 within one week before study entry
- Experiencing a major depressive episode lasting at least four weeks
- Have a primary care provider or psychiatrist in the community
- Radial artery pulse with adequate ulnar collateral flow and no metal or foreign objects in both wrists
- Agree to follow lifestyle considerations
- Healthy controls must be aged 18 to 70 years, in good general health without cognitive impairment, and meet similar screening and adherence requirements
You will not qualify if you...
- Clinically significant abnormalities on EKG or lab tests, including creatinine >1.3 mg/dL
- Use of prohibited medications within two weeks (five weeks for certain drugs) before screening
- Current psychotic features or diagnosis of schizophrenia or other psychotic disorders
- Psychiatric inpatient hospitalization within the past year
- Substance use disorder within the past three months, except caffeine or nicotine dependence
- Serious suicidal or homicidal risk, recent suicidal ideation or behavior, or history of aggressive behavior
- Unstable medical conditions making participation unsafe
- HIV infection or pregnancy
- Inability to travel to NIH
- Recent radiation exposure exceeding allowable limits
- Inability to lie still and flat for at least two hours during imaging
- Contraindications to MRI such as implanted electrical devices, metal fragments, or permanent eyeliner
- Use of cytochrome P450 enzyme inducers
- NIH staff or employees who are subordinates, relatives, or co-workers of the investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
T
Tara N Turon, C.R.N.P.
CONTACT
R
Robert B Innis, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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