Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial

This study is not yet open for participant recruitment.
Verified June 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Mario R. Louza, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01633593
First received: June 29, 2012
Last updated: July 3, 2012
Last verified: June 2012

June 29, 2012
July 3, 2012
August 2012
August 2014   (final data collection date for primary outcome measure)
reduction of the duration of delirium in elderly patients treated with donepezil [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01633593 on ClinicalTrials.gov Archive Site
Severity of delirium (as measured by the DSR-98-R) may influence the response to donepezil [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial
Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial

Nowadays features for the diagnosis of delirium are:

  1. Disturbance of consciousness (i.e. reduced clarity of environment awareness) with reduced ability to focus, sustain or shift attention;
  2. A change in cognition (such as memory deficit, disorientation, language disturbance) or the development of a perceptual disturbance that is not better accounted for by a pre-existing or evolving dementia;
  3. The disturbance develops over a short period of time (usually hours to days) and its severity fluctuates during the course of the day;
  4. There is evidence from the history, physical examination, or laboratory findings that the disorder is caused by the direct physiological consequences of a general medical condition, substance intoxication or substance withdrawal.

Treatment of underlying clinical disease is important to remit the delirium. However, these procedures alone are not enough to remit the delirium early and to prevent sequels. There is a need for a specific and faster strategy to treat the delirium.

The investigators want to test the hypothesis that an Anticholinesterase Inhibitor (donepezil) can reduce the duration of the delirium.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Elderly
  • Delirium of Unknown (Axis III) Etiology
  • Intensive Care (ICU) Myopathy
Drug: Donepezil
5 mg PO a day, during 2 weeks
  • Experimental: donepezil
    Donepezil 5mg/day during 2 weeks
    Intervention: Drug: Donepezil
  • Placebo Comparator: placebo
    placebo comparator to donepezil (double blind)
    Intervention: Drug: Donepezil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
190
August 2016
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Over 60 year old
  • Delirium according to the CAM-ICU (Confusion Assessment Method for Intensive Care Unit)
  • informed consent (legal representatives)

Exclusion Criteria:

  • unable to swallow pills
  • previous allergy to donepezil
  • Atrioventricular block of 2nd and 3nd degree
Both
60 Years and older
No
Not Provided
Not Provided
 
NCT01633593
deliriumBR2012, 2010/10810-1, Pfizer
No
Mario R. Louza, MD, PhD, University of Sao Paulo
University of Sao Paulo
Not Provided
Not Provided
University of Sao Paulo
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP