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

Phase 1

Recruiting

• Conditions: Depression
• Interventions: Drug: 11C-MCI; Drug: 11CPS13

• Registration Number: NCT04582916
• Lead Sponsor: National Institute of Mental Health (NIMH)

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

Detailed Description

Study Description: This study will examine whether cyclooxygenase 1 (COX-1) and cyclooxygenase-2 (COX-2) are detectable in the brain of individuals with major depressive disorder (MDD).

Objectives: Primary Objective: To determine whether COX-1 and COX-2 are detectable in the brains of individuals with MDD experiencing a major depressive episode (MDE).

Endpoints: Primary Endpoints: Group A - Calculation of COX-2 density from \[11C\]MC1 PET scans, using baseline scans and scans after blockade with celecoxib. Group B - Calculation of the density of COX-1 using \[11C\]PS13

Secondary Endpoints, common to both groups:

1. the relationship between peripheral markers of inflammation and COX binding;

2. the relationship between clinical rating scales and COX binding

Study Timeline

• Study First Submitted: 2020-10-09
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-12
• Study Start: 2021-07-20
• Status Verified: 2025-04-02
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Primary Completion: 2029-10-03
• Study Completion: 2030-04-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One Arm	11CPS13	All subject receive the same tests
One Arm	11C-MCI	All subject receive the same tests

Primary Outcome Measures

Name	Time	Method
Measure the concentration of radioligands	36 months	Tracer binding level

Secondary Outcome Measures

Name	Time	Method
measure clinical rating scales and COX binding	36 months	Assess the severity of depression and/or anxiety
measure peripheral markers of inflammation and COX binding	36 months	Assess the severity of depression and/or anxiety

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States