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[11C]-(R)-Rolipram Imaging for Depression

Phase 1
Waitlist Available
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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 minutes after injection of 11c-r-rolipram
Awards & highlights

Study Summary

This trial is testing whether ketamine affects brain cells with low levels of cAMP, which may cause depression.

Who is the study for?
Adults aged 18-70 with major depression, who haven't responded to two antidepressant treatments or ECT/TMS, can join this trial. They must be in good health, understand the study and consent to it, use contraception if applicable, and already be part of specific NIH ketamine studies.Check my eligibility
What is being tested?
The trial is testing how a drug called [11C]-(R)-Rolipram can measure changes in brain cAMP levels before and after administering ketamine to people with depression. It involves PET scans using a radioactive drug and MRI scans over five visits.See study design
What are the potential side effects?
Possible side effects may include discomfort from lying still during scans for up to two hours, reactions to the radioactive drug used for PET scanning (though generally minimal), and any known side effects from ketamine treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 minutes after injection of 11c-r-rolipram
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 minutes after injection of 11c-r-rolipram for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Whole Brain Total Distribution Volume (VT)
Secondary outcome measures
Measure of Level of Depression Using Montgomery-Åsberg Depression Rating Scale (MADRS)
Measure of Level of Depression Using the Hamilton Depression (HAM-D) Rating Scale

Trial Design

1Treatment groups
Experimental Treatment
Group I: Subjects with major depression disorder (MDD)Experimental Treatment1 Intervention
Participants with major depressive disorder received 20 mCi of [11C](R)-rolipram intravenously for two PET scans, prior to and after ketamine infusion as well as brain MRI

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor
2,798 Previous Clinical Trials
2,660,917 Total Patients Enrolled
672 Trials studying Depression
253,342 Patients Enrolled for Depression
Robert B Innis, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
27 Previous Clinical Trials
1,303 Total Patients Enrolled
4 Trials studying Depression
184 Patients Enrolled for Depression

Media Library

Subjects with major depression disorder (MDD) Clinical Trial Eligibility Overview. Trial Name: NCT05522673 — Phase 1
Depression Research Study Groups: Subjects with major depression disorder (MDD)
Depression Clinical Trial 2023: Subjects with major depression disorder (MDD) Highlights & Side Effects. Trial Name: NCT05522673 — Phase 1
Subjects with major depression disorder (MDD) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05522673 — Phase 1
~0 spots leftby Jun 2025
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