Trial Information
Early Recognition and Optimal Treatment of Delirium in Patients With Advanced Cancer
Inclusion Criteria:
- Patient has been diagnosed with advanced cancer
- Age ≥ 18
- Patient or his / her significant other speaks Dutch fluently
Exclusion Criteria:
- Delirium is due to alcohol withdrawal
- Patient has been diagnosed with glaucoma, Parkinson's disease or dementia
- Patient is being treated with other neuroleptic medication or lithium
- Patient has another psychiatric disorder that is considered (by investigator) to
interfere with assessment of delirium
- Patient had a QTc-interval of > 480 msec on ECG made on admission to the medical
oncology ward (ECG is not required if patient is admitted to a high-care hospice)
- Patient has a history of neuroleptic malignant syndrome
- Patient has a history of convulsions.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Outcome Measure:
DRS-R-98 severity rating score
Outcome Description:
Primary endpoint for this trial is a DRS-R-98 severity rating score <15,25, as this is a measure for establishing clearance of delirium.
Outcome Time Frame:
Until clearance of the delirium signs or for a maximum of 2 weeks
Safety Issue:
No
Principal Investigator
Henk MW Verheul, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
VU University Medical Center
Authority:
Netherlands: Central Committee on Research involving Human Subjects (CCMO)
Study ID:
2009/225
NCT ID:
NCT01539733
Start Date:
March 2010
Completion Date:
February 2014
Related Keywords:
- Delirium
- Advanced Cancer
- Delirium
- Neoplasms