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

This terminated diagnostic trial (n=1) aimed to measure the effects of ketamine infusion on cyclic AMP (cAMP) signalling in the brain using [11C]-(R)-Rolipram.

Major depressive disorder (MDD) is associated with alterations in cAMP signalling. Ketamine, a drug used to treat depression, may affect cAMP levels in the brain. This trial, conducted by the National Institute of Mental Health (NIMH), aimed to investigate if ketamine administration to individuals with MDD would lead to changes in cAMP signalling in their brains.

Participants, aged 18 to 70 with MDD, were enrolled in other NIH studies using ketamine. They underwent screening, including physical exams, psychiatric evaluations, and PET scans with [11C]-(R)-Rolipram to measure cAMP signalling. After ketamine infusion, participants underwent another PET scan to measure changes in cAMP levels. Additionally, MRI scans were conducted.

Primary outcomes included changes in PDE4 density (volume of distribution VT) in the brain before and after ketamine administration. Secondary outcomes included clinical rating scales of depression, such as the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Hamilton Depression (HAM-D) Rating Scale.

The trial, which began on February 8, 2023, was terminated on January 30, 2024, due to low recruitment. It was conducted at the National Institutes of Health Clinical Center in Bethesda, Maryland, USA.

Trial Details

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....

Trial Number NCT05522673

Data attribution

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