Prevention of neuropsychiatric adverse effects caused by dexamethasone: insights from a placebo-controlled trial with hydrocortisone.

Phase 4

Recruiting

Conditions: Depressie, Manie, Angst, Cognitie, Slaap
Psychiatric adverse effects and sleep
10012221

Registration Number: NL-OMON54782

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

- Cranial glioma, meningioma or brain metastasis scheduled to undergo surgery
(resection)
- Minimal dose of peri-operative cumulative dexamethasone 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary parameter is neuropsychiatric adverse effects measured by the Brief<br /><br>Psychiatric Rating Scale (BPRS).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are neuropsychiatric adverse effects measured with<br /><br>different questionnaires (Hospital Anxiety and Depression Scale, Altman<br /><br>Self-Rating Mania scale, Positive Affect Negative Affect Scale, Delirium<br /><br>Observation Scale); neurophysiological functioning assessed with different<br /><br>cognitive tests, sleep quality measured with the Leeds Sleep Evaluation<br /><br>Questionnaire (LSEQ) and quality of life with QLQ-C30+BN20.</p><br>