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Hydrocortisone as co-treatment to prevent neuropsychiatric adverse effects of dexamethasone.


- candidate number28397
- NTR NumberNTR6937
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-jan-2018
- Secondary IDs2017-003705-17 // 40-41200-98-9291 ZonMw
- Public TitleHydrocortisone as co-treatment to prevent neuropsychiatric adverse effects of dexamethasone.
- Scientific TitlePrevention of neuropsychiatric adverse effects caused by dexamethasone: translational insights from a placebo-controlled trial with hydrocortisone.
- ACRONYMDEXA-CORT
- hypothesisCo-treatment with a physiological dose of hydrocortisone will prevent or reduce neuropsychiatric adverse effects caused by dexamethasone.
- Healt Condition(s) or Problem(s) studiedAnxiety, Depression, Cognition, Manic depressive illness, Sleep, Delirium
- Inclusion criteria- Cranial glioma or meningioma scheduled to undergo surgery (resection + biopsy)
- 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
- Patients with already low dose dexamethasone are allowed in the study
- Exclusion criteria- Non-native speakers of Dutch or insufficient command of the Dutch language
- Patients who need consultation for psychiatric symptoms
- Patients that are unable to overview consequences of trial participation
- Patients that are not able to fill in the questionnaires because of cognitive impairments at the discretion of the physician
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2018
- planned closingdate1-apr-2021
- Target number of participants200
- InterventionsHydrocortisone or placebo as add-on to dexamethasone.
- Primary outcomeThe primary parameter is neuropsychiatric adverse effects measured by the Brief Psychiatric Rating Scale (BPRS).
- Secondary outcomeSecondary parameters are neuropsychiatric adverse effects measured with different questionnaires (Hospital Anxiety and Depression Scale, Altman Self-Rating Mania scale, Positive Affect Negative Affect Scale and Visual Analogue Scales); 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.
- TimepointsThis study has 8 to 10 timepoints in which different questionnaires, interviews, cognitive tests will be performed. Burden is approximately 4 to 5 hours.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Anne-Sophie Koning
- CONTACT for SCIENTIFIC QUERIESProf. dr. Onno Meijer
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publications
- Brief summaryOver 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.
- Main changes (audit trail)
- RECORD4-jan-2018 - 18-jan-2018


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