HALO Trial: Haloperidol vs Olanzapine in Hyperactive Delirium in Palliative Care Patients; A Multi-Centre, Randomised-Controlled Trial
Key facts
- Who runs it
- Tan Tock Seng Hospital
- Where
- Singapore3 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 3
- People taking part
- 22 people enrolled
- Started
- 18 May 2022
- Ended
- 25 Sept 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Haldol 2mg/ml oral solution
- Olanzapine Actavis 5mg orodispersible tablet
- Record updated
- 5 October 2026
Who can take part
- Age
- 21 years to 99 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Patients with advanced cancer or end-stage organ disease
- Age ≥ 21 years old
- Fulfil All Three Diagnosis of Delirium:; Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria for delirium; Memorial Delirium Assessment Scale (MDAS)©1996 >/= 13; Richmond Agitation-Sedation Scale (RASS) Score +1 to +3
- Able to consume medications orally
- Prognosis > 48 hrs (Clinician Estimate)
Who cannot take part
- Chronic Schizophrenia on regular Anti-psychotic medications
- Taking any regular Benzodiazepines* or any Anti-psychotic** medications
- Unable to consume oral medications
- Parkinson's Disease or Vascular Parkinsonism
- Patient with dementia
- Known allergy to Haloperidol or Olanzapine
- History of Substance Abuse
- Known Prolonged corrected QT interval (QTc) Syndrome (In Patient's Medical History)
- Prognosis < 48 hours (Clinician's Estimate)
- Richmond Agitation and Sedation Scale (RASS) Score +4 (Too agitated and will require Parenteral Anti-psychotics and/or Benzodiazepines)
- Pregnancy * e.g. Lorazepam, Alprazolam, Clonazepam, Midazolam **e.g. Haloperidol, Risperidone, Quetiapine, Olanzapine
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
1. Background and Clinical Need:
Read full original descriptionShow less
Delirium is common at the end of life and is challenging to control. There is a clinical need to study the benefits of commonly used drugs like Haloperidol and Olanzapine in the management of hyperactive delirium in advanced cancer or end-stage organ disease patients in a scientifically robust manner. 2. Aims/Hypotheses:
The investigators aim to study the effectiveness of Haloperidol compared with Olanzapine in the management of hyperactive delirium in advanced cancer or end-stage organ disease patients receiving palliative care. The investigators hypothesise that Olanzapine is as effective as Haloperidol in the control of hyperactive delirium. 3. Methods:
The investigators will conduct a pragmatic, multi-centre, (hospital, inpatient hospice, community hospital) open-label randomised-controlled trial comparing the use of Haloperidol versus Olanzapine in advanced cancer or end-stage organ disease patients with hyperactive delirium.
The primary outcome is the change in Richmond Agitation and Sedation Scale (RASS) scores among patients in each treatment group at 8 hours post-drug administration.
The secondary outcome is the control of hyperactive delirium at 24, 48 and 72 hours using either Haloperidol or Olanzapine.
The mean doses of Haloperidol and Olanzapine used as well as the volume of rescue Midazolam required as well as side-effects of the study medications, survival after enrolment into study will also be studied. 4. Significance to palliative care The results of this study will advance the knowledge of delirium management worldwide with regards to the efficacy of Haloperidol and Olanzapine in managing hyperactive delirium in patients with advanced cancer or end-stage organ disease.
Haloperidol is used traditionally in palliative care for managing delirium. However, as a conventional anti-psychotic, it does cause extra-pyramidal side-effects. Olanzapine, a newer atypical anti-psychotic with a more favourable side-effect profile is being used increasingly in the control of delirium. These 2 commonly used drugs have never been compared head to head in a randomised-controlled, multi-centre study.
The 2 groups in the trial
- Haloperidol ArmExisting treatment, for comparison
Haldol 2mg/ml oral solution
Treatment: Haldol 2mg/ml oral solution
- Olanzapine ArmExisting treatment, for comparison
Olanzapine Actavis 5mg orodispersible tablet
Treatment: Olanzapine Actavis 5mg orodispersible tablet
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 5 October 2026