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

Funding

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 .... 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 total delirium score reduction, and do not guide management of target symptomatology. There as been no systematic evaluation of toxicity profile in relation to delirium management with typical or atypical antipsychotics, in particular extrapyramidal toxicity and degree of sedation. There is need for randomized control trial evidence of the efficacy of antipsychotics to control targeted delirium symptoms, and also to consider broader implications on caregiver and patient distress.
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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) .... • 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.
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