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Early Recognition and Optimal Treatment of Delirium in Patients With Advanced Cancer

18 Years
Open (Enrolling)
Delirium, Advanced Cancer

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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:


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:


Principal Investigator

Henk MW Verheul, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

VU University Medical Center


Netherlands: Central Committee on Research involving Human Subjects (CCMO)

Study ID:




Start Date:

March 2010

Completion Date:

February 2014

Related Keywords:

  • Delirium
  • Advanced Cancer
  • Delirium
  • Neoplasms