Health TrialsbyHealthPanel

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

ConditionDepression
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNational Institute of Mental Health (NIMH)

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

18 to 70 years of age.

Female participants of childbearing potential must be using a medically acceptable means of contraception.

Be in good general health as evidenced by medical history and physical examination. Stable medical conditions as assessed by their primary care provider (PCP) and/or in-house clinician are permitted to join the study.

Each participant must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.

Disqualifiers

Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two-times the upper limit or even lower values in the investigator s judgment. Creatinine level >1.3 mg/dL.

Participants must be free of all prohibited medications for at least two weeks (5 weeks for aripiprazole, brexpiprazole, fluoxetine) prior to screen visit. These medications include antidepressants, antipsychotics, anxiolytics, psychotropic drugs not otherwise specified

Current psychotic features, a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-5.

Participants with a history of psychiatric inpatient hospitalization within the past year.

Trial design

Design model

Single group

Treatments tested in this trial

  • Lung scan

    Radiation

    Immediately after the brain scan

  • Apremilast

    Drug

    Oral administration of apremilast

  • 18F-PF-06445974

    Drug

    Injected IV followed by PET scanning

Treatment groups

108 Participants
are divided into 1 treatment group
Group A: one armOther 3 interventions

Trial outcomes

Primary outcomes

1

To measure distribution volume

Target quantification

Time frame
36 months

Secondary outcomes

1

To determine the optimal length

Target quantification

Time frame
36 months
2

To measure whole-brain distribution volume in retest

Target quantification

Time frame
36 months
3

measure clinical rating scales and PDE4B binding

Assess the severity of depression

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Mental Health (NIMH)

Lead sponsor

Source ClinicalTrials.gov
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