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

Phase 3

Completed

• Conditions: delirium; Neurological - Dementias

• Registration Number: ACTRN12607000562471
• Lead Sponsor: Flinders University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-01
• Study Completion: 2014-04-24
• Last Update Posted: 24 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 171

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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]