Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05703685
The ClinicalTrials.gov registry entry for NCT05703685 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (86% lower). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
-
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
RECRUITING · Phase 1
-
PET Imaging of Cyclooxygenase in Participants With Major Depressive Disorder (MDD)
RECRUITING · Phase 1
-
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
RECRUITING · Phase 1
-
Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans
RECRUITING · Phase 1
-
Feasibility and Safety of Ketamine for Suicidal Patients in the Emergency Department
RECRUITING · Phase 1
-
A Study to Explore the Effect of SP-624 on Brain Network Analytics in Healthy Adults and Adults With Major Depression
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.