A phase III randomised, double-blind placebo controlled study to compare the effectiveness of oral Risperidone and oral Haloperidol in the management of delirium

Cancer Symptom Trials (CST)

Dataset description

Dataset includes: - Two hundred forty-seven participants were included in intention-to-treat analysis (82 receiving risperidone, 81 receiving haloperidol, and 84 receiving placebo. Treatment period over 72 hours while inpatient, with follow-up for 4 weeks post treatment where possible. Data available for demographic, medical history data, concurrent medications, and baseline clinical measures. Primary outcome data measured by as Nursing Delirium Screening Scale (items 2, 3 and 4), safety and toxicity data measured using the NCI CTCAE V3.0, Extrapyramidal symptom rating scale (ESRS), and sedation subscale of Richmond Agitation Sedation scale. Other data for secondary analysis include; Australia-modified Karnofsky Performance Status (measured at baseline, treatment cessation and end of follow-up), Mini Mental Status Examination (measured at baseline, treatment cessation and discharge from hospital), pulse oximetry (measured at baseline, and daily during intervention), Cumulative Illness Rating Scale (measured at baseline and delirium resolution), sedation (measured at baseline and daily during intervention), Nursing Delirium Screening Scale (measured at baseline and each shift during intervention), the Memorial Delirium Assessment Scale (measured at baseline, daily, delirium resolution, IQCODE for caregivers (measured at baseline), Distress for Nurses, caregivers (measured at baseline, treatment cessation or delirium resolution) and patients (measured at delirium resolution and week 4 follow-up), nursing hours of care, and health care utilisation.
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Source Study

Trial acronym

Risperidone and haloperidol in delirium

Trial ID





Phase 3


Government body,Commonwealth Department of Health and Ageing

Scientific enquiries

A/Prof Meera Agar

Brief Summary

Delirium is prevalent in patients with advanced cancer and in the palliative care setting, and is associated with significant and distressing symptomatology and poor prognosis. Antipsychotics are considered by most clinicians as first line pharmacotherapeutic agents for delirium despite limited randomized double blind controlled evidence for management of delirium in any health care setting, including palliative care. The few studies that exist explore post treatment efficacy in relation to tota ....
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Key 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.

Key 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) ....
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Can healthy volunteers participate?




Sample Size    171

Min. age    18 Years

Max. age    0 Not stated

Sex    Both males and females

Condition category    delirium

Condition code    Neurological


Intervention code Treatment: Drugs

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.


Control group Placebo

Oral placebo syrup (water and preservative, standared base for the study drugs) twice daily for 3 days.


Outcome: 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.
Timepoint: 72 hours

Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

Individual Participant Data

When will data be available?

01/06/2023 to 01/06/2031

Available to whom?

Researchers undertaking secondary research

Available for what types of analyses?

Those analyses described in approved proposals only

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see