[18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET

Exclusion Criteria

• •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 for at least two weeks (5 weeks for aripiprazole, brexpiprazole, fluoxetine) prior to screen visit. These medications include antidepressants, antipsychotics, anxiolytics, psychotropic drugs not otherwise specified
• •(including herbal products), and sedatives/hypnotics.
• •Current psychotic features, a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-5.
• •Participants with a history of psychiatric inpatient hospitalization within the past year.
• •Participants who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.
• •Participants with suicidal ideation within the past 6 months.
• •Participants with suicidal behavior within the past 12 months.
• •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).
• •HIV infection.
• •Pregnancy.
• •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.
• •Be NIMH staff or an NIH employee who is a subordinate/relative/co-worker of the investigators.
• •Healthy controls 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).
• •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, antipsychotics, anxiolytics, psychotropic drugs not otherwise specified (including herbal products), and sedatives/hypnotics.
• •Participants who have a history of major depressive disorder.
• •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).
• •HIV infection.
• •Pregnancy.
• •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.
• •Use of cytochrome P450 enzyme inducers (e.g. rifampin, phenobarbital, carbamazepine, phenytoin).
• •Be NIMH staff or an NIH employee who is a subordinate/relative/co-worker of the investigator.