PET Imaging of Cyclooxygenase in Participants With Major Depressive Disorder (MDD)
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|ClinicalTrials.gov Identifier: NCT04582916|
Recruitment Status : Recruiting
First Posted : October 12, 2020
Last Update Posted : November 26, 2020
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 if COX-2 is measurable in the brains of people with MDD who are having a major depressive episode (MDE).
To learn if COX-2 is detectable in the brains of people with MDD who are having an MDE.
Healthy people ages 18 70 years old with MDD.
Participants will be screened under protocol 01-M-0254. They will have a medical history, physical exam, and psychiatric evaluation. They will have blood tests. They will have an electrocardiogram (EKG) to measure heart function.
Participants will have a magnetic resonance imaging (MRI) scan of the brain. MRI uses a strong magnetic field and radio waves to take pictures. The MRI scanner is a metal cylinder. Participants will lie on a table that slides in and out of the cylinder. The machine makes loud knocking noises. Participants will get earplugs or earmuffs.
Participants will have 2 PET scans of the brain. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. A plastic mask will be shaped to fit their head. An intravenous (IV) catheter will be put into a vein of the arm. A small amount of the radioactive chemical [11C]MC1 will be injected through the IV catheter. Another catheter will be put into an artery at the wrist or elbow crease and used to draw blood. Participants vital signs will be recorded. They will have EKGs and give urine samples. Participation lasts 1 to 2 weeks.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: 11C-MCI Drug: Drug||Phase 1|
Study Description: This pilot/exploratory study will examine whether cyclooxygenase 2 (COX-2) is detectable in the brain of individuals with major depressive disorder (MDD).
Primary Objective: To determine whether COX-2 is detectable in the brains of individuals with MDD experiencing a major depressive episode (MDE).
Endpoints: Primary Endpoint: Calculation of COX-2 density from [11C]MC1 PET scans, using baseline scans and scans after blockade with celecoxib. Secondary Endpoints: 1) the relationship between peripheral markers of inflammation and COX binding
2) the relationship between clinical rating scales and COX binding
Study Population: Sixteen (16) medication-free participants with MDD will be recruited. 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: Participants will be intravenously injected with 20 mCi of [11C]MC1 twice, once at baseline and once after blockade by celecoxib. 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study: PET Imaging of Cyclooxygenase in Participants With Major Depressive Disorder (MDD)|
|Estimated Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||May 29, 2023|
|Estimated Study Completion Date :||August 29, 2023|
All subject receive the same tests
Injected IV followed by PET scanning
- Measure the concentration of radioligands [ Time Frame: 36 months ]Tracer binding level
- measure peripheral markers of inflammation and COX binding [ Time Frame: 36 months ]Assess the severity of depression and/or anxiety
- measure clinical rating scales and COX binding [ Time Frame: 36 months ]Assess the severity of depression and/or anxiety
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582916
|Contact: Maria M Araneta||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Robert B Innis, M.D.||National Institute of Mental Health (NIMH)|