Condition category
Signs and Symptoms
Date applied
12/09/2005
Date assigned
28/10/2005
Last edited
14/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Alistair Burns

ORCID ID

Contact details

2nd Floor
Education and Research Centre
Wythenshawe Hospital
Manchester
M23 9LT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Delirium

Intervention

Rivastigmine up to 1.5 mg twice a day or placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Rivastigmine

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

Overall trial start date

01/04/2004

Overall trial end date

01/07/2006

Reason abandoned

Eligibility

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 type

Patient

Age group

Senior

Gender

Both

Target number of participants

50

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

Recruitment start date

01/04/2004

Recruitment end date

01/07/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

2nd Floor
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

South Manchester University Hospitals NHS Trust (UK)

Sponsor details

Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

Novartis (UK) - paid for tablets only

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

South Manchester University Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20353624

Publication citations

  1. Results

    Overshott R, Vernon M, Morris J, Burns A, Rivastigmine in the treatment of delirium in older people: a pilot study., Int Psychogeriatr, 2010, 22, 5, 812-818, doi: 10.1017/S1041610209991359.

Additional files

Editorial Notes