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

Depression Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

• NCT number: NCT04582916
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Tara N Turon, C.R.N.P.
• Phone: (301) 827-6599
• Email: tara.turon@nih.gov
• Status: Recruiting
• Phase: Phase 1
• Start date: July 20, 2021
• Completion date: April 11, 2030