Early recognition and optimal treatment of delirium in patients with advanced cancer
Phase 3
Completed
- Conditions
- confusiondelirium1002765610012221
- Registration Number
- NL-OMON39561
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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 (except for low dose neuroleptics used in the treatment of neuropathic pain);
* Patient has another psychiatric disorder that is considered (by investigator) to interfere with assessment of delirium;
* Patient had a QTc-interval of > 500 msec on ECG made on admission;
* Patient has a history of neuroleptic malignant syndrome;
* Patient has a history of convulsions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint for this trial is a DRS-R-98 severity rating score < 15,25 and<br /><br>a decline > 4.5 points on the total scale.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoint is the amount of time elapsed between start of treatment and<br /><br>diminishing of the signs of delirium. (DOS < 3, DSR-R-98 < 15,25)</p><br>