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RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 5 visits
  • Procedures mentioned: Blood draws, Physical exams, MRI scans, PET scans, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Design: Participants will have up to 5 clinic visits."
  • "They will have a physical exam with blood tests."
  • "Participants will have magnetic resonance imaging (MRI) of the brain."
  • "Participants blood pressure, heart rate, and breathing will be monitored before, during, and after the PET scan."
  • "Some participants may return for a second PET scan; have a lung scan or receive apremilast. https://nimhcontent.nimh.nih.gov/start/surveys/?s=KE88DXXPLDFHHTF8"
  • "To determine the optimal length for PDE4B scans with \[18F\]PF-06445974 PET scans in healthy volunteers 2."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses PET brain scans and an experimental radioactive tracer to measure PDE4B, an enzyme in the brain. Researchers want to see if PDE4B levels are lower during a major depression episode. Adults ages 18–70 with major depression and healthy volunteers may join.

Background: Major depressive disorder (MDD) is a psychiatric condition. People with MDD have occasional bouts of depressive symptoms; these bouts are called major depressive episodes (MDEs). Researchers want to know if people having MDEs have lower levels of an enzyme called PDE4B in their brains. Primary Objective: To determine whether PDE4B is reduced in the brains of individuals with MDD experiencing a major depressive episode (MDE). Secondary Objectives: To determine the optimal length of scanning and the retest variability and reliability of \[18F\]PF-06445974, and whether PDE4B binding correlates with clinical rating scales. To measure if PDE4B radioligand binding can be blocked by taking apremilast. Eligibility: People aged 18-70 years with MDD. Healthy volunteers are also needed. Design: Participants will have up to 5 clinic visits. Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. Some participants may have a psychiatric assessment; they will answer questions about their state of mind and related topics. Participants will have magnetic resonance imaging (MRI) of the brain. They will lie on a table that slides into a metal cylinder. Participants will have a positron emission tomography (PET) scan. A needle will be used to guide a thin plastic tube (catheter) into a vein in one arm. An experimental substance called a radioactive tracer (\[18F\]PF-06445974) will be injected through the catheter. Participants will lie on a table that slides into a doughnut-shaped machine. The scan will last up to 4 hours with a 15-minute break. Participants blood pressure, heart rate, and breathing will be monitored before, during, and after the PET scan. A second catheter will be inserted in the artery of the wrist so blood can be drawn during the scan. Some participants may return for a second PET scan; have a lung scan or receive apremilast. https://nimhcontent.nimh.nih.gov/start/surveys/?s=KE88DXXPLDFHHTF8

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–70 years old and in good general health. Stable health conditions may be allowed.
  • Be able to understand the study, agree to its tests, and sign a consent form.
  • Complete the required screening or enroll in the required screening study for your group.
  • If you can become pregnant, use a medically accepted form of birth control.
  • Have enough blood flow in your wrists, with no metal or other foreign objects in either wrist.
  • Agree to follow the study’s lifestyle rules.
  • For the depression group: have major depression without psychosis, such as seeing things that are not there. The current episode must last at least 4 weeks, and depression test scores must meet study limits. Have a local primary care doctor or psychiatrist.
  • For healthy volunteers: have no problems with memory or thinking.

Who can't join

  • Serious problems on heart or blood tests, an unstable illness that makes the study unsafe, HIV infection, or pregnancy.
  • Use of medicines the study does not allow within 2 weeks before screening, or 5 weeks for aripiprazole, brexpiprazole, or fluoxetine. These include certain mood, anxiety, and sleep medicines and herbal products. Healthy volunteers also cannot use certain medicines that affect liver enzymes.
  • A current drug or alcohol use disorder, or a substance use disorder in the past 3 months, except caffeine or nicotine dependence. Alcohol or cannabis use alone does not rule you out unless it affects daily life.
  • For the depression group: a disorder involving loss of touch with reality, current psychosis symptoms, or a hospital stay for mental health care in the past year.
  • For the depression group: serious current risk of harming yourself or others, suicidal thoughts in the past 6 months, suicidal behavior in the past year, or a history of aggression toward others.
  • For healthy volunteers: any history of major depression.
  • Unable to travel to NIH, lie flat and still for at least 2 hours, or safely have an MRI. Recent research radiation exposure that would put you above allowed limits also rules you out.
  • Being NIMH staff, or an NIH employee who works under, is related to, or works with a study investigator.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* INCLUSION CRITERIA: Patients: In order to be eligible for this study, MDD participants must meet all of the following criteria: * 18 to 70 years of age. * Female participants of childbearing potential must be using a medically acceptable means of contraception. * Be in good general health as evidenced by medical history and physical examination. Stable medical conditions as assessed by their primary care provider (PCP) and/or in-house clinician are permitted to join the study. * 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 01-M-0254, 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 \>= 18 or HAM-D \>= 15 within one week of study entry. * Participants must be experiencing an MDE lasting at least four weeks. * All MDD participants must have a PCP or psychiatrist in the community. * 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. 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 with a history of DSM-5 substance use disorder (except for caffeine or nicotine dependence) within the preceding three months. In addition, participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily life. * 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 with a history of DSM-5 substance use disorder (except for caffeine or nicotine dependence) within the preceding three months. In addition, participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily life. * 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.

Study sites (1)

MD