Effects of the pattern of glucocorticoid replacement on neural processing, emotional reactivity and well-being in healthy male individuals: study protocol for a randomised controlled trial

Trials
Konstantinos KalafatakisStafford L Lightman

Abstract

Deviation from the physiological glucocorticoid dynamics (circadian and underlying ultradian rhythmicity) is a common characteristic of various neuropsychiatric and endocrine disorders as well as glucocorticoid-based therapeutics. These states may be accompanied by neuropsychiatric symptomatology, suggesting continuous dynamic glucocorticoid equilibrium is essential for brain homeostasis. The study consists of two parts. The preliminary stage of the study aims to validate (technically and pharmacologically) and optimise three different patterns of systemic cortisol administration in man. These patterns are based on the combinatory administration of metyrapone, to suppress endogenous cortisol production, and concurrent hydrocortisone replacement. The second, subsequent, core part of the study is a randomised, double-blinded, placebo-controlled, crossover study, where participants (healthy male individuals aged 18-60 years) will undergo all three hydrocortisone replacement schemes. During these infusion regimes, we plan a number of neurobehavioural tests and imaging of the brain to assess neural processing, emotional reactivity and perception, mood and self-perceived well-being. The psychological tests include: ecological momenta...Continue Reading

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Citations

Feb 16, 2020·Endocrine Reviews·Stafford L LightmanBecky L Conway-Campbell
Apr 11, 2018·Proceedings of the National Academy of Sciences of the United States of America·K KalafatakisS L Lightman

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CRICBristol
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statistical parametric mapping ( SPM )
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Functional Magnetic Resonance Imaging of the Brain ( FMRIB ) S...
ECAT
SPSS®
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Animas®
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