Comparing Haloperidol and Olanzapine for Treating Hyperactive Delirium in Palliative Care Patients
HALO Trial: Haloperidol vs Olanzapine in Hyperactive Delirium in Palliative Care Patients; A Multi-Centre, Randomised-Controlled Trial
This study tests whether Haloperidol or Olanzapine works better to help manage hyperactive delirium in patients with advanced cancer or serious organ disease who are receiving palliative care.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 21 Years to 99 Years |
| Sex | All |
| Sponsor | Tan Tock Seng Hospital Academic / other |
| Locations | 3 sites (Singapore and 2 other locations) |
| Trial ID | NCT04833023 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of Haloperidol versus Olanzapine in managing hyperactive delirium among patients with advanced cancer or end-stage organ disease receiving palliative care. It is a multi-centre, open-label, randomised-controlled trial that aims to provide robust evidence on the use of these commonly prescribed medications. The study will include patients who meet specific diagnostic criteria for delirium and will assess their response to treatment over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with advanced cancer or end-stage organ disease who exhibit symptoms of hyperactive delirium.
Not a fit: Patients with Parkinson's Disease, dementia, or those on regular anti-psychotic medications are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of hyperactive delirium, enhancing the quality of life for patients in palliative care.
How similar studies have performed: Previous studies have shown varying results regarding the effectiveness of anti-psychotics in delirium management, but this specific comparison of Haloperidol and Olanzapine in a multi-centre setting is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with advanced cancer or end-stage organ disease 2. Age ≥ 21 years old 3. 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 4. Able to consume medications orally 5. Prognosis \> 48 hrs (Clinician Estimate) Exclusion Criteria: 1. Parkinson's Disease or Vascular Parkinsonism 2. Patient with dementia 3. Chronic Schizophrenia on regular Anti-psychotic medications 4. Taking any regular Benzodiazepines\* or any Anti-psychotic\*\* medications 5. Known allergy to Haloperidol or Olanzapine 6. History of Substance Abuse 7. Known Prolonged corrected QT interval (QTc) Syndrome (In Patient's Medical History) 8. Prognosis \< 48 hours (Clinician's Estimate) 9. Unable to consume oral medications 10. Richmond Agitation and Sedation Scale (RASS) Score +4 (Too agitated and will require Parenteral Anti-psychotics and/or Benzodiazepines) 11. Pregnancy \* e.g. Lorazepam, Alprazolam, Clonazepam, Midazolam \*\*e.g. Haloperidol, Risperidone, Quetiapine, Olanzapine
Where this trial is running
Singapore and 2 other locations
- Tan Tock Seng Hospital — Singapore, Singapore (Recruiting)
- Dover Park Hospice — Singapore, Singapore (Recruiting)
- St. Andrew's Community Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Mervyn Koh — Tan Tock Seng Hospital
- Study coordinator: Mervyn Koh
- Email: mervyn_koh@ttsh.com.sg
- Phone: +6597678996
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.