Oral risperidone, oral haloperidol, and oral placebo in the management of delirium in palliative care.

• Register: ANZCTR
• Last refreshed on: 24 April 2023
• Main ID: ACTRN12607000562471
• Date of registration: 01/11/2007
• Prospective Registration: Yes
• Primary sponsor: Flinders University
• Public title: Oral risperidone, oral haloperidol, and oral placebo in the management of delirium in palliative care.
• Scientific title: Oral risperidone, oral haloperidol, and oral placebo in the management of delirium in palliative care.
• Date of first enrolment: 13/08/2008
• Target sample size: 165
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12607000562471.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 3

Countries of recruitment

Australia

Contacts

• Name: A/Prof Meera Agar

• Name: A/Prof Meera Agar

Key inclusion & exclusion criteria

Inclusion criteria: • Diagnosis of Delirium as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM IVR) criteria for delirium ( a standard diagnotic manual for defining mental disorders) and MDAS score
• Score on Nursing Delirium screening scale
• English speaking.
• Proxy written informed consent.
• Cancer or non-cancer life limiting illness.
Exclusion criteria: • Delirium due to alcohol or other withdrawal syndrome where more specific treatment is indicated.
• Current or past history of neuroleptic malignant syndrome.
• Antipsychotic use within past 7 days.
• Maintenance on antipsychotic required for other diagnosis.
• Previous adverse reaction to any of the study medications.
• Established Parkinson’s disease or other extrapyramidal disorder.
• Documented prolonged QT (QT is the relationship between two conduction points on an electrocardiograph (ECG) syndrome
• Clinician predicted survival less than seven days.
• Cerebrovascular accident with in the last month.
• Seizure within the last month.
• Pregnant or breastfeeding.

Age minimum: 18 Years
Age maximum: Not stated
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Neurological - Dementias

delirium;
delirium

Intervention(s)

Oral risperidone (0.5 to 2mg according to response) twice daily for 3 days, vs oral haloperidol twice daily (0.5 to 2mg according to response) for 3 days.

Primary Outcome(s)

Sum of scores on Nursing Delirium screening scale - items 2 (inappropriate behaviour), 3 (inappropriate communication), and 4 (illusions/hallucinations). The primary null hypothesis is no difference between oral risperidone and ora placebo at 72 hours from treatment commencement.[72 hours]

Secondary Outcome(s)

Efficacy
10.Caregiver rated distress.[Day 3]

Efficacy
8.Patient reported recall after delirium resolution[48 hours after MDAS < 7]

6.Percentage of patients who have delirium recurrence after 48 hours of MDAS < 7.[48 hours of MDAS < 7]

Efficacy
3.Number/total dosage of midazolam[Number of hours from administration of first study dose.]

Toxicity:
1.Extrapyramidal toxicity:[72 hours]

Efficacy
5.Patients who did not require rescue dosage[72 hours]

Efficacy:
1.Time to discontinuation of therapy (hours)rescue usage[72 hours and various timepoints for follow-up data]

Efficacy
7.Time profile of Memorial Delirium Assessment Scale scores[Daily for 3 days]

Serum apoptosis marker levels:[At the time of delirium resolution. Within the 3 days of intervention, or during the study follow-up period.]

Health service utilisation and long term outcomes:
1.Medical complications during admission
2.Death.
3.Cognitive impairment
4.Functional decline.
5.Usage of Assistants in Nursing (hours) during delirium episode.
6.Nursing home placement.
7.Length of admission in palliative care unit (days).
8.Survival outside of institutional care (days).[12 months]

Efficacy
4.Memorial Delirium Assessment Scale (MDAS) score < 7[72 hours]

Efficacy
11.Nursing staff rated distress.[Day 3]

Toxicity
3.Adverse events[Twice daily for the 3 days of intervention.]

Toxicity
2.Sedation:[7 days]

Efficacy
9.Patient rated distress after delirium resolution.[At time of delirium resolution, this may be within the 3 days of the study intervention, or during the follow-up period.]

Efficacy
Time to first rescue midazolam[Number of hours from administration of first study dose.]

Secondary ID(s)

002/07

Source(s) of Monetary Support

Commonwealth Department of Health and Ageing

Secondary Sponsor(s)

Commonwealth Department of Health and Ageing

Ethics review

Status: Approved
Approval date: 06/02/2008
Contact:

Repatriation General Hospital

Status: Approved
Approval date: 22/05/2008
Contact:

Flinders Cliical Research Ethics Committee

Status: Approved
Approval date: 16/06/2008
Contact:

Mater Health Services Human Research Ethics Committee

Status: Approved
Approval date: 03/07/2008
Contact:

Cancer Institute NSW

Status: Approved
Approval date: 24/07/2008
Contact:

Peter MaCallum Cancer Centre Ethics Committee

Status: Approved
Approval date: 25/03/2009
Contact:

Ballarat Health Services & St John of God Health Care Ethics Committee

Status: Approved
Approval date: 08/04/2010
Contact:

St John of God Health Care Ethics Committee

Results

• Results available: Yes
• Date Posted: 13/04/2023
• Date Completed: 24/04/2014