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NCT05703685 · ClinicalTrials.gov registry record · Phase 1
[18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET
A Phase 1 study of Depression, sponsored by National Institute of Mental Health (NIMH).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 108
- Enrollment target
- 1
- Study location
NCT05703685: Recruiting Phase 1 study of Depression, sponsored by National Institute of Mental Health (NIMH).
NCT05703685 is a Phase 1 study of Depression that is actively recruiting participants, run by National Institute of Mental Health (NIMH). The registered enrollment target is 108 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05703685, a Phase 1 study of Depression, is actively recruiting participants, sponsored by National Institute of Mental Health (NIMH).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 108 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
Target quantification
Conditions Studied
Interventions
- DRUG 18F-PF-06445974
- RADIATION Lung scan
- DRUG Apremilast
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2023-06-22 |
| Est. Completion | 2029-04-11 |
| Phase | Phase 1 |
What NCT05703685 shows while recruiting
NCT05703685 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Depression appearing as the primary indexed condition, and to 3 interventions - of which 18F-PF-06445974 is the first listed.
NCT05703685 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05703685 about?
NCT05703685 is a clinical study titled "[18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET". 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. ...
What is the current status of trial NCT05703685?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 108 participants. The study started on 2023-06-22. Estimated completion is 2029-04-11.
What conditions does trial NCT05703685 study?
This clinical trial studies the following conditions: Depression.
What interventions are being tested in trial NCT05703685?
The interventions under investigation include: 18F-PF-06445974 (DRUG), Lung scan (RADIATION), Apremilast (DRUG).
Who is sponsoring clinical trial NCT05703685?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05703685 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05703685's enrollment target sits among peer trials
108 311th of 679 higher than 366 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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