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

Summary

Participation Requirements

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 wi...

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: the relationship between peripheral markers of inflammation and COX binding; the relationship between clinical rating scales and COX binding Study Population: Group A) Sixteen (16) medication-free participants with MDD; Group B) Three groups of 16 subjects each will be studied: 1) Medicated MDD, 2) Unmedicated MDD and 3) healthy volunteers. Participants may be male or female. They must be between 18 and 70 years old. Individuals may be recruited from anywhere but, for those participating in the outpatient study, most are expected to come from the Washington DC metropolitan area. MDD participants must be in good medical health and provide informed consent. Description of Sites/Facilities Enrolling Participants: Screening and PET imaging will be performed at the NIH Clinical Center. Description of Study Intervention: Group A - Participants will be intravenously injected with 20 mCi of [11C]MC1 twice, once at baseline and once after blockade by celecoxib. Group B - Subjects will be intravenously injected once with 20 mCi of [11C]PS13 and For both groups, participants will also have a radial artery catheter(s) inserted to measure radioligand concentration before each scan. Participants will also have a brain MRI to provide anatomic orientation for the PET scans. Study Duration: 36 months Participant Duration: One to two weeks, depending on the participant's availability and investigators' overall access to MRI and PET cameras.

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