Effects of menstrual cycle phase in glucocorticoid-induced neuropsychiatric disorders: a prospective cohort study

Abstract

BACKGROUND. Glucocorticoids are widely used. Unfortunately, they are not exempt of adverse effects, including glucocorticoid-induced neuropsychiatric disorders. These do not have any preventive strategy, as there is still unknown information about its aetiopathogenesis and risk factors. An unclear one is female sex. Existent literature tables some hypotheses, such as the interaction between hypothalamus-pituitary-adrenal axis and hypothalamus-pituitary-gonadal axis. This happens between responses of cortisol to psychosocial stress and menstrual cycle phases, so this originates the hypothesis of a possible contribution of menstrual cycle to these induced disorders. OBJECTIVES. The main objective of this study is to determine if there is a variation in the incidence of glucocorticoid-induced neuropsychiatric disorders across the phases of the menstrual cycle, in women with a regular cycle and no use of hormonal contraception, who are undergoing corticotherapy at high dosages, depending on the phase when they start the treatment. Secondary objectives aim to evaluate the type of disorder, other risk factors, and the necessity of pharmacological management. DESIGN. This is an unicentric prospective cohort study to be done by the Psychiatric Interconsultation Service of Hospital Santa Caterina and Hospital Josep Trueta. PARTICIPANTS. Women aged 18-45 with a regular cycle and no use of hormonal contraception, who are undergoing corticotherapy at 40 mg/day or more of prednisone or its equivalent, with no mental disorder in the past 6 months or current. METHODS. 204 participants will be enrolled using a consecutive sampling method with a time of recruitment of 2 years. Women will be divided into two groups according to the phase of the cycle when they start the treatment (follicular or luteal) using LH tests and menses self-report. Data about other risk factors will be collected. They will be followed during a maximum of 6 months to assess if they develop an induced disorder, using MINI Plus, PHQ-9 and MMSE to help in the diagnosis. Information about a pharmacologic management will also be collected