Co-treatment with a physiological dose of hydrocortisone will prevent or reduce neuropsychiatric adverse effects caused by dexamethasone.
ID
Source
Brief title
Health condition
anxiety, depression, mania, delirium, sleep, cognition
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameter is neuropsychiatric adverse effects measured by the Brief Psychiatric Rating Scale (BPRS).
Secondary outcome
Secondary parameters are neuropsychiatric adverse effects measured with different questionnaires (Hospital Anxiety and Depression Scale, Altman Self-Rating Mania scale and Positive Affect Negative Affect Scale); neurophysiological functioning assessed with different cognitive tests, sleep quality measured with actigraphy and the Leeds Sleep Evaluation Questionnaire (LSEQ) and quality of life with QLQ-C30+BN20.
Background summary
Over 800.000 individuals are treated annually in The Netherlands with synthetic glucocorticoids like dexamethasone. These drugs are life-saving but induce significant neuropsychiatric complaints in thousands of patients. Dexamethasone acts only via glucocorticoid receptors (GRs), while the endogenous hormone hydrocortisone stimulates in brain also mineralocorticoid receptors (MRs). An unwanted side effect of dexamethasone is the strong suppression of hydrocortisone levels. This depletes brain MRs from ligand, which is known to compromise brain function. We hypothesize that co-treatment with a physiological dose of hydrocortisone will re-fill brain MRs and prevent - or strongly reduce - psychopathology caused by synthetic glucocorticoids.
Study objective
Co-treatment with a physiological dose of hydrocortisone will prevent or reduce neuropsychiatric adverse effects caused by dexamethasone.
Study design
This study has 8 to 10 timepoints in which different questionnaires, interviews, cognitive tests will be performed. Burden is approximately 5 to 6 hours.
Intervention
Hydrocortisone or placebo as add-on to dexamethasone.
Inclusion criteria
- Cranial glioma or meningioma scheduled to undergo surgery (resection) - Minimal dose of peri-operative cumulative dexamethasone exposure of 24mg or more in 6 days - ≥18 years - Good clinical condition; KPS≥70 - Life expectancy ≥6 months
Exclusion criteria
- Non-native speakers of Dutch or insufficient command of the Dutch language - Patients that are unable to overview consequences of trial participation - Patients with severe aphasia - Patients that are not able to fill in the questionnaires because of cognitive impairments at the discretion of the physician - Patients with psychiatric diseases or neurological deficits that interfere with the study to the judgement of treating physician
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6726 |
| NTR-old | NTR6937 |
| Other | ZonMw : 2017-003705-17 // 40-41200-98-9291 |
| CCMO | NL63350.058.18 |
| OMON | NL-OMON54782 |