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

NCT04582916 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 20015720-M-0157
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Depression

Keywords

PET Imaging; Inflammation; Cyclooxygenase-2; Depression

Outcome Measures

Primary Outcomes (1)

• Measure the concentration of radioligands

  Tracer binding level

  36 months

Secondary Outcomes (2)

• measure peripheral markers of inflammation and COX binding

  36 months

• measure clinical rating scales and COX binding

  36 months

Study Arms (1)

One Arm

OTHER

All subject receive the same tests

Drug: 11C-MCI; Drug: 11CPS13

Interventions

11C-MCI DRUG

Injected IV followed by PET scanning

One Arm

11CPS13 DRUG

Injected IV followed by PET scanning

One Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients: In order to be eligible for this study, MDD participants must meet all of the following criteria:
• Aged 18 to 70 years old.
• Female participants of childbearing potential must be using a medically acceptable means of contraception.
• Participants must be in good general health as evidenced by medical history and physical examination.
• Each participant must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
• All participants must have undergone a screening assessment under protocol 01M0254, The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants .
• Participants must fulfill DSM-5 criteria for major depression (MDD) without psychotic features, as based on clinical assessment and structured diagnostic interview (SCID-P).
• Participants must have an initial score on the MADRS greater than or equal to 18 or HAM-D greater than or equal to 15 within one week of study entry.
• Participants must be experiencing an MDE lasting at least four weeks.
• Unmedicated participants in both Groups must be medication-free for at least two weeks (5 weeks for aripirazole, brexpiprazole, fluoxetine) prior to first screen visit. Medications will not be discontinued for the purpose of this study.
• Participants must have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.
• Participants must agree to adhere to the lifestyle considerations.
• Healthy Controls: In order to be eligible to participate in this study, control subjects must meet all of the following criteria:
• Aged 18 to 70 years old.
• Female participants of childbearing potential must be using a medically acceptable means of contraception.

You may not qualify if:

• Participants with MDD who meet any of the following criteria will be excluded from participation in this study:
• Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two-times the upper limit or even lower values in the investigator s judgment. Creatinine level \>1.3 mg/dL.
• Participants must be free of all prohibited medications or at least two weeks (5 weeks for aripiprazole, brexpiprazole, fluoxetine) prior to screen visit. These medications include antidepressants, anti-inflammatory drugs (except for study medication celecoxib), antipsychotics, anxiolytics, psychotropic drugs not otherwise specified (including herbal products), and sedatives/hypnotics. Medicated participants in Group B may continue their therapy.
• Participants should not have taken Non-Steroidal Anti-Inflammatory Drug (NSAID)s for two weeks prior to the PET scan. Aspirin, corticosteroids (with the exception of topical steroids), or immunosuppressants (e.g. methotrexate) must not have been taken in the prior month.
• Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-5.
• Participants who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.
• Participants who have a history of aggressive behavior towards others.
• Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).
• Participants seeking treatment or a change in treatment and may be referred to the community or to another research study.
• Are unable to travel to the NIH.
• Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.
• Have an inability to lie flat and/or lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.
• Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.
• Pregnancy.
• HIV Infection.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Depression; Inflammation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert B Innis, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tara N Turon, C.R.N.P.

CONTACT

(301) 827-6599; tara.turon@nih.gov

Robert B Innis, M.D.

CONTACT

(301) 594-1368; robert.innis@nih.gov

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 12, 2020
• Study Start: July 20, 2021
• Primary Completion (Estimated): October 3, 2029
• Study Completion (Estimated): April 11, 2030
• Last Updated: March 13, 2026

Record last verified: 2026-03-09

Locations

US (1)