Hydrocortisone as co-treatment to prevent neuropsychiatric adverse effects of dexamethasone.
- Conditions
- anxiety, depression, mania, delirium, sleep, cognition
- Registration Number
- NL-OMON22627
- Lead Sponsor
- eiden Univeristy Medical Center (LUMC)
- Brief Summary
Regardless of the outcome, trial results will be submitted for publication in a peer-reviewed journal and presented at conferences.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 180
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary parameter is neuropsychiatric adverse effects measured by the Brief Psychiatric Rating Scale (BPRS).
- Secondary Outcome Measures
Name Time Method 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.