Clinical trial for Depression
Official title [18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET
ClinicalTrials.gov ID: NCT05703685
What this study is testing
What is Apremilast?
An investigational oral medication being studied for depression.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if the enzyme PDE4B is reduced in the brains of people having a major depressive episode. It also looks at how long the scan should last, how reliable the scan is, and if the enzyme level relates to depression scores.
- Who it's for
- Adults aged 18 to 70 who have major depressive disorder, and also healthy volunteers.
- What's involved
- Participants will have up to five clinic visits that include a physical exam, blood tests, a heart‑function test, a brain MRI, and a PET scan with a radioactive tracer. Blood pressure, heart rate, and breathing will be monitored, and blood samples may be taken during the scan.
- Time commitment
- The study lasts up to five visits over several weeks, with each PET scan lasting up to four hours including a short break.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- 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.
- 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...
You likely can't join if
- Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea...
- Participants must be free of all prohibited medications for at least two weeks (5 weeks for aripiprazole, brexpiprazole, fluoxetine) prior to screen...
- 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.
- Participants who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.
See the full eligibility criteria
Who can join
- 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.
- 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.
What rules you out
- 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 for at least two weeks (5 weeks for aripiprazole, brexpiprazole, fluoxetine) prior to screen visit.
- 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.
- 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...
- 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...
- 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.
- Participants with a history of DSM-5 substance use disorder (except for caffeine or nicotine dependence) within the preceding three months.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.