PET Imaging of Cyclooxygenase in Participants With Major Depressive Disorder (MDD)
ConditionDepression
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNational Institute of Mental Health (NIMH)
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 11C-MCI
- 11CPS13
Treatment groups
64 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov