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

Who is this study for? Patients with Depression
What treatments are being studied? 11C-MCI+11CPS13
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
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‣ 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.

• Able to provide informed consent.

• Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.

• Be enrolled in 01M0254, The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17M0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies .

• 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.

• Agree to adhere to the lifestyle considerations.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Tara N Turon, C.R.N.P.
tara.turon@nih.gov
(301) 827-6599
Backup
Robert B Innis, M.D.
robert.innis@nih.gov
(301) 594-1368
Time Frame
Start Date: 2021-07-20
Estimated Completion Date: 2030-04-11
Participants
Target number of participants: 64
Treatments
Other: One Arm
All subject receive the same tests
Related Therapeutic Areas
Sponsors
Leads: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov