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
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