drugset / Trial / NCT05522673

[11C]-(R)-Rolipram to Measure cAMP Signaling Before and After Ketamine

NCT05522673 ↗

Phase 1 Terminated 1 enrolled National Institute of Mental Health (NIMH)
NaSingle-groupOpen-labelDiagnostic

Summary

Background: Major depressive disorder (MDD) may have many underlying causes. One theory is that brain cells with low levels of a molecule called cyclic AMP (cAMP) may cause depression. A drug called ketamine may increase the levels of cAMP in a person's brain cells. Objective: To find out if administering ketamine to people with depression affects cAMP levels in their brains. Eligibility: People aged 18 to 70 with MDD who are enrolled in another NIH study that uses ketamine. Design: Participants will visit the NIH clinic 5 times in up to 6 weeks. Some of the visits may be spread out over more than 1 day. Participants will be screened. They will have a physical exam with blood and urine tests. They will have a test of their heart function. They will have a psychiatric evaluation. They will answer questions about their family history and mental health. Participants will have a positron emission tomography (PET) scan. A small amount of a radioactive drug will be injected into a vein in their arm. Participants will lie on a bed that slides in and out of a doughnut-shaped machine that records images of their brains. They will have their heads in a holder to prevent movement. Each scan will last up to 2 hours. After their first PET scan, participants will receive ketamine in a different study they are enrolled in. Then they will come back for another PET scan with the radioactive drug. Participants will also have another scan called an MRI. They will lie on a table that slides into a metal tube. They will lie still for up to an hour....

Timeline

Start
2023-02-08
Primary completion
2023-02-08
Completion
2024-01-30

Outcome

Outcome not reported

Stopped (Enrollment): “Low recruitment”

Drugs

EvaluationDrugModalityDoseRoute
Subject 11(R)-rolipram Unknown 740 mbq Intravenous