Co-treatment with a physiological dose of hydrocortisone will prevent or reduce neuropsychiatric adverse effects caused by dexamethasone.
ID
Bron
Verkorte titel
Aandoening
anxiety, depression, mania, delirium, sleep, cognition
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary parameter is neuropsychiatric adverse effects measured by the Brief Psychiatric Rating Scale (BPRS).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Co-treatment with a physiological dose of hydrocortisone will prevent or reduce neuropsychiatric adverse effects caused by dexamethasone.
Onderzoeksopzet
This study has 8 to 10 timepoints in which different questionnaires, interviews, cognitive tests will be performed. Burden is approximately 5 to 6 hours.
Onderzoeksproduct en/of interventie
Hydrocortisone or placebo as add-on to dexamethasone.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6726 |
| NTR-old | NTR6937 |
| Ander register | ZonMw : 2017-003705-17 // 40-41200-98-9291 |
| CCMO | NL63350.058.18 |
| OMON | NL-OMON54782 |