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NCT04582916 · ClinicalTrials.gov registry record · Phase 1
PET Imaging of Cyclooxygenase in Participants With Major Depressive Disorder (MDD)
A Phase 1 study of Depression, sponsored by National Institute of Mental Health (NIMH).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT04582916 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 64 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04582916, 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
- 64 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Researchers developed \[11C\]MC1, a radioligand for cyclooxygenase-2 (COX-2). COX-2 is an enzyme induced in the brain during inflammation. Researchers want to see the levels of COX-1 (measured as distribution volume VT) are elevated in the brain of two groups of mood disorders patients undergoing MDE relative to the control group. Objective: To determine whether COX-1 and COX-2 are detectable in the brains of individuals with MDD experiencing a major depressive episode (MDE). Eligibility: People aged 18-70 years with MDD and Healthy Volunteers aged 18 70 years. Design: Group A: MDD participants will be studied with the same dose of \[11C\]MC1 before and after administration of 600 mg celecoxib; the study is neither randomized nor placebo-controlled. Group B: MDD participants, both medicated and unmedicated, will be studied with \[11C\]PS13 and compared to healthy volunteers.. https://nimhcontent.nimh.nih.gov/start/surveys/?s=TJW4RA4WN3LDD988
Conditions Studied
Interventions
- DRUG 11C-MCI
- DRUG 11CPS13
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2021-07-20 |
| Est. Completion | 2030-04-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04582916
The ClinicalTrials.gov registry entry for NCT04582916 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 64 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 (92% 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 2 interventions - of which 11C-MCI is the first listed.
NCT04582916 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04582916 about?
NCT04582916 is a clinical study titled "PET Imaging of Cyclooxygenase in Participants With Major Depressive Disorder (MDD)". Background: Researchers developed \[11C\]MC1, a radioligand for cyclooxygenase-2 (COX-2). COX-2 is an enzyme induced in the brain during inflammation. Researchers want to see the levels of COX-1 (measured as distribution volume VT) are elevated in the brain of two groups of mood disorders patients ...
What is the current status of trial NCT04582916?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2021-07-20. Estimated completion is 2030-04-11.
What conditions does trial NCT04582916 study?
This clinical trial studies the following conditions: Depression.
What interventions are being tested in trial NCT04582916?
The interventions under investigation include: 11C-MCI (DRUG), 11CPS13 (DRUG).
Who is sponsoring clinical trial NCT04582916?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04582916 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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