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

Depression Clinical Trial

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

Status Terminated

Clinical Trial 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....

Clinical Trial Description

Study Description:

This study will test the effects of ketamine infusion on the cAMP system in human brain to determine if ketamine mediates its antidepressant effects at least in part due to modulation of cAMP signaling.

Objectives:

Primary Objective: To determine if ketamine infusions in depression causes increases in cAMP signaling as measured by [11C](R)-rolipram binding.

Secondary Objectives: To determine if increases in [11C](R)-rolipram correlate with symptomatic improvement in major depressive symptoms.

Endpoints:

Primary Endpoint: measurement of PDE4 density (volume of distribution VT) in brains of individuals with major depressive disorder (MDD) before and after administration of ketamine.

Secondary Endpoints: Clinical rating scales of depression, including MADRS, HAM-D. ;

Related Conditions & MeSH terms

• Depression

• NCT number: NCT05522673
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Terminated
• Phase: Phase 1
• Start date: February 8, 2023
• Completion date: January 30, 2024