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[18F]PF-06445974 PET Imaging for Depression

Phase 1
Recruiting
Led By Robert B Innis, M.D.
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial studies changes in an enzyme in the brain to see if it's lower in people with major depressive disorder during major depressive episodes.

Who is the study for?
Adults aged 18-70 with Major Depressive Disorder (MDD) and healthy volunteers are eligible for this trial. Participants must be in good health, use contraception if of childbearing potential, have a primary care provider or psychiatrist, and agree to lifestyle considerations. Exclusions include recent suicidal behavior, psychiatric hospitalization within the past year, substance abuse disorders within three months (except caffeine/nicotine), unstable medical conditions, HIV infection, pregnancy, inability to undergo MRI scans or lie still for PET scans.Check my eligibility
What is being tested?
The study is testing an experimental radioactive tracer called [18F]PF-06445974 using PET scans to detect PDE4B enzyme levels in the brain and determine if these levels are lower during major depressive episodes. The process involves up to five clinic visits including screening tests like physical exams and blood tests; MRI scanning; PET scanning with continuous monitoring of vital signs; and possibly a second PET scan.See study design
What are the potential side effects?
Potential side effects from the radioactive tracer used in the PET scan may include discomfort at injection site or allergic reactions. Continuous monitoring during the procedure will help ensure any immediate adverse effects can be managed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To measure distribution volume
Secondary outcome measures
To determine the optimal length
To measure whole-brain distribution volume in retest
measure clinical rating scales and PDE4B binding

Trial Design

1Treatment groups
Experimental Treatment
Group I: one armExperimental Treatment1 Intervention
All subjects will receive the same tests

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor
2,786 Previous Clinical Trials
2,689,653 Total Patients Enrolled
666 Trials studying Depression
251,528 Patients Enrolled for Depression
Robert B Innis, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
27 Previous Clinical Trials
1,248 Total Patients Enrolled
4 Trials studying Depression
129 Patients Enrolled for Depression

Media Library

one arm Clinical Trial Eligibility Overview. Trial Name: NCT05703685 — Phase 1
Depression Research Study Groups: one arm
Depression Clinical Trial 2023: one arm Highlights & Side Effects. Trial Name: NCT05703685 — Phase 1
one arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05703685 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age eligibility criterion for prospective participants in this trial?

"Patients wishing to be included in this study must fall between 18 and 70 years old. For those under the age of majority, there are 211 trials available; for seniors above 65, 1006 medical studies have been posted."

Answered by AI

Who can partake in this investigation?

"This clinical trial is recruiting approximately 56 patients, who must suffer from depression and be between 18 to 70 years of age."

Answered by AI

What are the associated risks of this particular therapeutic approach?

"Our in-house evaluation of the treatment's safety rated it a 1, because this is an experimental Phase 1 trial with limited data demonstrating its efficacy and security."

Answered by AI

How many participants are contributing to the data of this experiment?

"Affirmative, the information found on clinicaltrials.gov indicates that this research study is currently enrolling patients; it was initially posted on June 20th 2023 and updated recently on June 14th of the same year. This endeavour seeks 56 individuals from a single medical centre."

Answered by AI

Are participants accepted for this research project currently?

"Affirmative. According to the information on clinicaltrials.gov, this trial is still recruiting participants after being initially posted on June 20th 2023 and edited as recently as June 14th same year. 56 people are needed across a single site for the study's completion."

Answered by AI

Who else is applying?

What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have tried other medical and traditional medications for depression to no avail. Currently tapering off my current medication.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
[18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET
2023. "[18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05703685.
All > Mdd
~37 spots leftby Oct 2028
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