11C-MCI / 11CPS13 / Depression · Phase 1 Trial

PET Imaging of Cyclooxygenase in Participants With Major Depressive Disorder (MDD)

ClinicalTrials.gov · August 18, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 1 recruitment-stage study registering a plan to measure COX-1 and COX-2 concentration in the brains of individuals with major depressive disorder using PET radioligands. No results are yet posted in this registry record. The study aims to establish whether these inflammatory markers are detectable in MDD and how they change with COX-2 inhibition, but clinical significance remains entirely unknown.

What was studied

Phase 1, Interventional, Single Group, Open label, Diagnostic purpose. Depression; age from 18 Years; to 70 Years; accepts healthy volunteers. Intervention: One Arm. Compared with: Group A: within-subject pre–post comparison with celecoxib. Group B: healthy volunteer controls.. n = 64. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This is a mechanistic imaging study in early stages; results are not yet available. If COX-1 or COX-2 elevation is confirmed in MDD brains, it may suggest a novel inflammatory target, but clinical relevance to diagnosis or treatment selection cannot be inferred from this registry record alone.

Plain-language summary

Phase 1 imaging study in recruitment with no posted results; designed to detect COX-1 and COX-2 in MDD brains using novel radioligands, but efficacy or clinical utility remain undemonstrated.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Measure the concentration of radioligands (assessed at 36 months)

DesignPhase 1, Interventional, Single Group, Open label, Diagnostic purpose

PopulationDepression; age from 18 Years; to 70 Years; accepts healthy volunteers

Sample size64

InterventionOne Arm

ComparatorGroup A: within-subject pre–post comparison with celecoxib. Group B: healthy volunteer controls.

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment64

PhasePhase 1

Primary outcome measureConcentration of radioligands (11C-MCI and 11C-PS13), 36 months

Age range18–70 years

Clinical bottom line

Caveats

Results are not yet posted; recruitment is ongoing.
No primary efficacy or clinical outcome measure is registered.
Group A is uncontrolled and non-randomized; Group B lacks randomization or blinding.
Phase 1 design addresses feasibility and detection, not clinical utility or treatment efficacy.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Phase 1, non-randomized, uncontrolled in Group A; Group B compares MDD to healthy controls only.

Directness

limited

Measures radioligand concentration and distribution volume; does not assess clinical outcomes or treatment response.

Consistency

insufficient

Single study at recruitment stage; no comparator literature cited or results reported.

Risk of bias

limited

Group A lacks randomization and placebo control; no blinding mentioned; recruitment ongoing.

Sample adequacy

limited

Estimated 64 participants total across two groups; Phase 1 imaging feasibility study.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT04582916). This is a study registration, not published results. Lead sponsor: National Institute of Mental Health (NIMH). Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 64 participants (ESTIMATED). Conditions: Depression. Interventions: DRUG: 11C-MCI; DRUG: 11CPS13. Primary outcome measures: Measure the concentration of radioligands , 36 months. Brief 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

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT0458291611C-MCI11CPS13DepressionNational Institute of Mental Health (NIMH)