Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial
Primary Purpose
Elderly, Delirium of Unknown (Axis III) Etiology, Intensive Care (ICU) Myopathy
Status
Terminated
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Donepezil
Sponsored by
About this trial
This is an interventional treatment trial for Elderly
Eligibility Criteria
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
Sites / Locations
- FAMEMA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
donepezil
placebo
Arm Description
Donepezil 5mg/day during 2 weeks
placebo comparator to donepezil (double blind)
Outcomes
Primary Outcome Measures
reduction of the duration of delirium in elderly patients treated with donepezil
Secondary Outcome Measures
Severity of delirium (as measured by the DSR-98-R) may influence the response to donepezil
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01633593
Brief Title
Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial
Official Title
Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruiting subjects for the trial.
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Nowadays features for the diagnosis of delirium are:
Disturbance of consciousness (i.e. reduced clarity of environment awareness) with reduced ability to focus, sustain or shift attention;
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;
The disturbance develops over a short period of time (usually hours to days) and its severity fluctuates during the course of the day;
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly, Delirium of Unknown (Axis III) Etiology, Intensive Care (ICU) Myopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
donepezil
Arm Type
Experimental
Arm Description
Donepezil 5mg/day during 2 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo comparator to donepezil (double blind)
Intervention Type
Drug
Intervention Name(s)
Donepezil
Intervention Description
5 mg PO a day, during 2 weeks
Primary Outcome Measure Information:
Title
reduction of the duration of delirium in elderly patients treated with donepezil
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Severity of delirium (as measured by the DSR-98-R) may influence the response to donepezil
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario R Louza, MD, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
FAMEMA
City
Marilia
State/Province
Sao Paulo
ZIP/Postal Code
1750000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial
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