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Minor2 versionsRe-verified since Dec 5, 2024, no change to tracked fieldsv113-v114
MinorEligibility criteria expanded, about 11 wordsv112
Show 35 earlier versionsHide 35 earlier versions
Minor2 versionsRe-verified since Sep 7, 2024, no change to tracked fieldsv110-v111
NotableEnrollment target: 56 to 108v109
Minor7 versionsRe-verified since Feb 28, 2024, no change to tracked fieldsv102-v108
NotablePrimary completion date: Oct 3, 2024 to Oct 3, 2028
Study completion date: Apr 11, 2025 to Apr 11, 2029
v101
Minor7 versionsRe-verified since Jul 28, 2023, no change to tracked fieldsv94-v100
MinorStudy Status, Eligibilityv93
MinorStart date changed from estimate of Jun 29, 2023 to Jun 22, 2023v92
MinorStart date: Jun 28, 2023 to Jun 29, 2023v91
MinorStart date: Jun 27, 2023 to Jun 28, 2023v90
MinorStart date: Jun 22, 2023 to Jun 27, 2023v89
MinorStart date: Jun 21, 2023 to Jun 22, 2023v88
MinorStart date: Jun 20, 2023 to Jun 21, 2023v87
MinorStart date: Jun 19, 2023 to Jun 20, 2023v86
MinorStart date: Jun 18, 2023 to Jun 19, 2023v85
MinorStart date: Jun 15, 2023 to Jun 18, 2023v84
MinorStart date: Jun 14, 2023 to Jun 15, 2023v83
MinorStart date: Jun 13, 2023 to Jun 14, 2023v82
MinorStart date: Jun 12, 2023 to Jun 13, 2023v81
MinorStart date: Jun 11, 2023 to Jun 12, 2023v80
MinorStart date: Jun 8, 2023 to Jun 11, 2023v79
MinorStart date: Jun 7, 2023 to Jun 8, 2023v78
MinorStart date: Jun 6, 2023 to Jun 7, 2023v77
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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