UnknownPhase 2

Comparing Haloperidol and Olanzapine in Treating Terminal Delirium

Singapore80 participantsStarted 2021-09-01

Plain-language summary

As patients with terminal illness enter the dying phase, they may experience symptoms of restlessness, agitation, or cognitive disturbance, known as terminal delirium. In community care, pharmacological therapies are utilized to manage the syndrome, the most commonly used being neuroleptics haloperidol and olanzapine. However, there is currently a dearth of studies on the efficacy and safety between haloperidol and olanzapine in the community palliative care setting; existing studies involve non-terminal patients in the hospital suffering from acute delirium. To fill this gap, an open-label randomized clinical trial is proposed to compare the effects of haloperidol and olanzapine in the management of terminal delirium in home hospice patients who are imminently dying. Key outcome measures are the reduction of delirium symptoms and the reduction of agitation. Secondary outcome is comparing the adverse effect burden on patients.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. Patient is above 21 years of age.
✓. Patient was diagnosed with a terminal illness and is receiving end-of-life care at home.
✓. Patient is assessed to be acutely dying (estimated prognosis of three days or less).
✓. Patient is diagnosed with delirium, as described in the DSM-V (American Psychiatric Association, 2013)

Exclusion criteria

✕. Patient does not have a caregiver at home.
✕. Patient has a prior history of dementia, psychosis, schizophrenia or any other mental health issue followed up by psychiatrists or other specialists.
✕. Patient is currently receiving, or has been administered Haloperidol or Olanzapine less than a week before participating in the study.
✕. Patient has known allergies or adverse reactions to Haloperidol or Olanzapine.
✕. Patients who survive 7 days after recruitment will be excluded from the study.

What they're measuring

Severity of agitation, measured by the Memorial Delirium Assessment Scale (MDAS)

Timeframe: 72 hours

Severity of terminal delirium, measured by the Richmond Agitation-Sedation Scale modified for palliative care (RASS-PAL)

Timeframe: 72 hours

Trial details

NCT IDNCT04750395

SponsorHCA Hospice Care

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05

Contact for this trial

Xiaojuan Lyu, MD

+65 97303814 xiaojuanl@hcahospicecare.org.sg

View on ClinicalTrials.gov More Delirium trials