Comparing Haloperidol and Olanzapine in Treating Terminal Delirium

• Status: Not yet recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HCA Hospice Care
• Treatments: Haloperidol; Haloperidol decanoate; Olanzapine

Criteria

Inclusion Criteria:

1. Patient is above 21 years of age.

2. Patient was diagnosed with a terminal illness and is receiving end-of-life care at home.

3. Patient is assessed to be acutely dying (estimated prognosis of three days or less).

4. Patient is diagnosed with delirium, as described in the DSM-V (American Psychiatric Association, 2013)

Exclusion Criteria:

1. Patient does not have a caregiver at home.

2. Patient has a prior history of dementia, psychosis, schizophrenia or any other mental health issue followed up by psychiatrists or other specialists.

3. Patient is currently receiving, or has been administered Haloperidol or Olanzapine less than a week before participating in the study.

4. Patient has known allergies or adverse reactions to Haloperidol or Olanzapine.

5. Patients who survive 7 days after recruitment will be excluded from the study.