Hydrocortisone as co-treatment to prevent neuropsychiatric adverse effects of dexamethasone.
- Conditions
- europsychiatric adverse effects which can be caused by dexamethasone. For example delirium, anxiety, depression, mania and psychosis. But also cognitive impairment and sleep disturbance.Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2017-003705-17-NL
- Lead Sponsor
- MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 180
Cranial glioma, meningioma or brain metastasis 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 (see attachments 1)
Life expectancy = 6 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
Non-native speakers of Dutch or insufficient command of the Dutch language
Patients that are unable to overview consequences of trial participation
Patients with 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method