A randomised placebo-controlled trial of rivastigmine in delirium in older medical in-patients: a pilot study | Not Recruiting
A randomised placebo-controlled trial of rivastigmine in delirium in older medical in-patients: a pilot study

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Delirium
Prof Alistair Burns
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Primary Contact Details
Not Recruiting
Recruitment Status
ISRCTN27327721
Primary Trial ID Number
Summary
Not provided at time of registration
Research Details
  • 1. The duration of delirium in people aged 65 or over on admission to an acute medical care of the elderly ward, or with onset at any time 3 weeks after admission, will be significantly less when treated with rivastigmine up to 3 mg daily compared to placebo, whether or not supplemented by risperidone 1 mg in divided doses daily 2. The proportion of older people who develop a delirium postoperatively following an orthopaedic procedure will be significantly less when treated with rivastigmine up to 3 mg daily compared to placebo, whether or not supplemented by risperidone 1 mg in divided doses daily 3. The percentage of patients who experience adverse events or complications on rivastigmine compared to placebo will be significantly less than those receiving treatment as usual 4. The percentage of patients who relapse after three delirium-free days after an episode of delirium will be significantly higher in those previously treated as usual than those treated with rivastigmine 5. These differences will remain significant irrespective of pre-admission cognitive function
Phase
Not Specified
Study Design
Randomised controlled trial
Study Type
Interventional
Intervention

Rivastigmine up to 1.5 mg twice a day or placebo.

Intervention Type
Drug
Primary Outcome Measures
  • 1. If develops delirium as found on Confusion Assessment Method
  • 2. Length of delirium, measured in days
Secondary Outcome Measures
  • 1. Length of admission
  • 2. Change in mini-mental state examination score
  • 3. Use of other psychotropic medication during treatment e.g. benzodiazepines
Publication(s)
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20353624
Result Reports
Sorry, this information is not available
Gender
Both
Age Range
Senior
Who Can Participate
Patient
Number of Participants
50
Participant Inclusion Criteria
  • 1. Patients over 65 years old
  • 2. Admitted to elderly acute medical ward or orthopaedic ward
  • 3. Patient has a delirium as measured on the Confusion Assessment Method or doesn't have a delirium and has a fractured neck of femur caused by trauma
Participant Exclusion Criteria
  • 1. Patient already on cholinesterase inhibitor
  • 2. Patient has had a previous adverse reaction to a cholinesterase inhibitor
  • 3. If considered by medical team in charge of care to be in the terminal phase of illness
  • 4. Acute chronic obstructive pulmonary disease (COPD) or asthma
  • 5. Has a dysrhythmia on electrocardiogram (ECG)
  • 6. Urea >20 or creatinine >200
Trial Location(s)
Pfizer Investigational Site
Manchester
M23 9LT
Trial Contact(s)
Primary Trial Contact
Prof Alistair Burns
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
Sorry, this information is not available
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Novartis (UK) - paid for tablets only
  • South Manchester University Hospitals NHS Trust (UK)
Other Study ID Numbers
3
Sponsor(s)
South Manchester University Hospitals NHS Trust (UK)
Key Dates

Recruitment Start Date

01 Apr 2004

Recruitment End Date

01 Jul 2006

Trial Start Date

01 Apr 2004

Trial End Date

01 Jul 2006

Date Assigned

28 Oct 2005

Last Updated

14 Jul 2010