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NCT04814355 · ClinicalTrials.gov registry record · Phase 4
The Effect of Celecoxib on Neuroinflammation in MDD
A Phase 4 study of Major Depressive Disorder and Neuroinflammation, sponsored by Stony Brook University.
- Active
- Registry status
- Phase 4
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT04814355: Active Phase 4 study of Major Depressive Disorder and Neuroinflammation, sponsored by Stony Brook University.
NCT04814355 is a Phase 4 study of Major Depressive Disorder and Neuroinflammation that is active but no longer recruiting, run by Stony Brook University. The registered enrollment target is 42 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04814355, a Phase 4 study of Major Depressive Disorder and Neuroinflammation, is active but no longer recruiting, sponsored by Stony Brook University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
Major depressive disorder (MDD) affects an estimated 350 million people worldwide and is a leading contributor to global disease burden. Commonly used monoamine reuptake-inhibiting treatments for depression are suboptimal, resulting in only 30% of patients achieving remission. This may be because monoamine dysfunction is not the primary pathophysiology in all MDD patients. One avenue for the development of novel MDD treatments is through anti-inflammatory drugs; MDD is linked to a pro-inflammatory phenotype characterized by microglial activation, leading to the release of pro-inflammatory cytokines and upregulation of cellular markers including cyclooxygenase-2 (COX-2) and translocator protein (TSPO; a protein located on the outer membrane of microglia). Relevant to this proposal, TSPO can serve as an in vivo marker of neuroinflammation using the newly developed positron emission tomography (PET) tracer for TSPO, \[18F\]FEPPA. In support of this, a recent \[18F\]FEPPA PET study found that MDD patients in a current major depressive episode (MDE) had significantly higher TSPO binding in the prefrontal cortex (PFC), anterior cingulate cortex (ACC) and insula, relative to healthy controls. The prefrontal cortex and ACC are both implicated in mood regulation whereas the insula is involved in interoceptive signaling, which is known to be abnormal in MDD. Celecoxib, a selective COX-2 nonsteroidal anti-inflammatory drug (NSAID), is a promising new treatment for neuroinflammation in MDD. Clinical studies have observed that, in a subset of depressed patients, celecoxib treatment reduced depression severity as assessed by the Hamilton Depression Rating Scale (HDRS). While these findings demonstrate that celecoxib reduces symptom severity, PET imaging technology is critical for understanding how celecoxib affects the underlying pathophysiology of depression. Here, the team will investigate neuroinflammation as an underlying pathology in depression and test whether neuroinflamma
Primary Outcome
Change in \[18F\]FEPPA VT (VT; volume of distribution: ratio of the concentration of radioligand in tissue to that in plasma at equilibrium)
Conditions Studied
Interventions
- DRUG Celecoxib 400 mg
Study Locations (1)
New York
- Psychiatry Department at Stony Brook University - Stony Brook
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2018-08-01 |
| Est. Completion | 2026-02 |
| Phase | Phase 4 |
What the registry record for NCT04814355 still lists
NCT04814355 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which Celecoxib 400 mg is the first listed.
NCT04814355 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04814355 about?
NCT04814355 is a clinical study titled "The Effect of Celecoxib on Neuroinflammation in MDD". Major depressive disorder (MDD) affects an estimated 350 million people worldwide and is a leading contributor to global disease burden. Commonly used monoamine reuptake-inhibiting treatments for depression are suboptimal, resulting in only 30% of patients achieving remission. This may be because mo...
What is the current status of trial NCT04814355?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 42 participants. The study started on 2018-08-01. Estimated completion is 2026-02.
What conditions does trial NCT04814355 study?
This clinical trial studies the following conditions: Major Depressive Disorder, Neuroinflammation.
What interventions are being tested in trial NCT04814355?
The interventions under investigation include: Celecoxib 400 mg (DRUG).
Who is sponsoring clinical trial NCT04814355?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04814355 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04814355's enrollment target sits among peer trials
42 194th of 282 higher than 89 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder 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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