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
27 weeks
Total Duration
On this page
AI-Summary
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 [18F]PF-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 [18F]PF-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.
CONDITIONS
Brief Title
[18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years
- Female participants of childbearing potential must use medically acceptable contraception
- Good general health as shown by medical history and physical exam
- Sufficient understanding to consent to tests and sign consent form
- Completed screening under related mood and anxiety disorder protocols
- Meet DSM-5 criteria for major depressive disorder without psychotic features
- Initial depression scores of MADRS ≥ 18 or HAM-D ≥ 15 within one week of entry
- Experiencing a major depressive episode lasting at least four weeks
- Have a primary care provider or psychiatrist in the community
- Radial artery pulse checked for adequate ulnar collateral flow and no metal in wrists
- Agree to follow lifestyle considerations
You will not qualify if you...
- Significant abnormalities on ECG or lab tests including CBC and metabolic panels
- Use of prohibited medications within two weeks (five weeks for some 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 past three months except caffeine or nicotine dependence
- Serious suicidal or homicidal risk or recent suicidal ideation or behavior
- History of aggressive behavior
- Unstable medical conditions making participation unsafe
- HIV infection or pregnancy
- Unable to travel to the study site
- Recent radiation exposure exceeding safe limits
- Inability to lie flat and still for at least two hours
- Unable to have MRI due to implants, devices, or metal fragments
- Use of certain enzyme-inducing medications
- NIMH staff or relatives/associates of investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants undergo brain PET scanning with an injected radioligand to image PDE4B, followed by a lung scan. Some participants will receive oral apremilast to assess its effect on radioligand binding.
1 baseline scan visit and 1 retest visit; additional visits for scans with apremilast administration
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.
R
Robert B Innis, M.D.
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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