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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 male or female, aged 18 to 70 years old.
Participants must be experiencing an MDE lasting at least four weeks.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial is designed to study whether COX-1 and COX-2 are detectable in the brains of individuals with MDD experiencing a major depressive episode (MDE).

Who is the study for?
This trial is for adults aged 18-70 with Major Depressive Disorder (MDD) currently having a depressive episode, and healthy volunteers of the same age range. Participants should be in good health overall, understand the study requirements, and agree to them by signing consent forms. Women who can have children must use birth control. People on certain medications must be off them for specific periods before starting.Check my eligibility
What is being tested?
[11C]MC1 and [11C]PS13 are being tested to detect COX-1 and COX-2 enzymes in the brain during depression. Group A will receive [11C]MC1 before/after celecoxib without randomization or placebo control; Group B's MDD patients (medicated/unmedicated) will be compared with healthy volunteers using [11C]PS13.See study design
What are the potential side effects?
Potential side effects aren't specified but may include reactions related to PET imaging such as discomfort at injection site or allergic reaction to tracers. Celecoxib can cause stomach pain, diarrhea, gas, headache, insomnia among other side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I have been feeling depressed for at least four weeks.
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I am in good health overall, as confirmed by my doctor.
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I haven't taken any medications for at least two weeks, or five weeks for specific drugs, before my first screening.

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
Measure the concentration of radioligands
Secondary outcome measures
measure clinical rating scales and COX binding
measure peripheral markers of inflammation and COX binding

Trial Design

1Treatment groups
Experimental Treatment
Group I: One ArmExperimental Treatment2 Interventions
All subject receive the same tests
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
11C-MCI
2022
Completed Phase 2
~10

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
2,783 Previous Clinical Trials
2,689,085 Total Patients Enrolled
665 Trials studying Depression
251,370 Patients Enrolled for Depression
Robert B Innis, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
27 Previous Clinical Trials
1,240 Total Patients Enrolled
4 Trials studying Depression
121 Patients Enrolled for Depression

Media Library

One Arm Clinical Trial Eligibility Overview. Trial Name: NCT04582916 — Phase 1
Depression Research Study Groups: One Arm
Depression Clinical Trial 2023: One Arm Highlights & Side Effects. Trial Name: NCT04582916 — Phase 1
One Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT04582916 — Phase 1
Depression Patient Testimony for trial: Trial Name: NCT04582916 — Phase 1

Frequently Asked Questions

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

Who meets the criteria to take part in this investigation?

"This medical trial is sourcing 64 individuals between 18 to 70 years old who are suffering from depression. Furthermore, they must adhere to the following conditions: male or female gender identity; comprehension of all clinical tests and examinations; females with childbearing potential need contraception; general healthiness as indicated by their history and physical exam; passed screening assessment under 01-M-0254 protocol ; minimum 4 weeks duration for MDE symptoms; medication-free status (5 weeks in case of aripiprazole, brexpiprazole, fluoxetine); primary care provider/inhouse clinician approved stable medical condition(s); DSM 5"

Answered by AI

What risks might be associated with this particular treatment?

"Following a review of the clinical data, our team at Power assigned this treatment a score of 1. This is because it is currently in Phase 1 trials with limited evidence supporting its safety and effectiveness."

Answered by AI

Is this study open to those under eighty-five years of age?

"This research project has set the minimum age for participants at 18 years old and capped off enrolment by those 70 or older."

Answered by AI

What is the aggregate amount of participants in this clinical experiment?

"Yes, this trial is actively enrolling patients. Per the information housed on clinicaltrials.gov, it was first posted on July 20th 2021 and last updated on September 22nd 2022; 64 individuals are sought after to join the single study site."

Answered by AI

Are there any vacancies remaining in this experiment for participants?

"The clinical trial is actively searching for participants, as evidenced by the information hosted on clinicialtrials.gov. The investigation was first posted in July 2021 and subsequently updated in September 2022."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
Virginia
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
3+

Why did patients apply to this trial?

I've tried many drugs over the years, as well as TMS and ECT. Nothing is helping.
PatientReceived 1 prior treatment
I’ve been on Sertraline for depression for more than 20 years. It allows me to function, but I hope for more.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. National Institutes of Health Clinical Center: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
PET Imaging of Cyclooxygenase in Participants With Major Depressive Disorder (MDD)
2021. "PET Imaging of Cyclooxygenase in Participants With Major Depressive Disorder (MDD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04582916.
All > Mdd > Treatment Resistant Depression
~42 spots leftby Oct 2029
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