Delirium Clinical Trial
— HALOLANOfficial title:
Open-label Randomized Controlled Trial of Oral Transmucosal Haloperidol and Olanzapine in the Treatment of Terminal Delirium
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Singapore | HCA Hospice Care | Singapore |
Lead Sponsor | Collaborator |
---|---|
HCA Hospice Care |
Singapore,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severity of agitation, measured by the Memorial Delirium Assessment Scale (MDAS) | MDAS is a ten-item, four-point clinician-rated scale designed to quantify the severity of delirium in medically-ill patients (range 1 - 40). Items included in the scale reflect the diagnostic criteria for delirium in the DSM-IV. It has very good psychometric proper-ties, with high reliability (r = .91) and good Discriminant and Concurrent validity. Though the scale was intended to assess patients based on all ten items, it was suggested that items in MDAS can be pro-rated in the event the patient is not able to communicate.
The higher the score, the more severe the agitation. |
72 hours | |
Primary | Severity of terminal delirium, measured by the Richmond Agitation-Sedation Scale modified for palliative care (RASS-PAL) | The RASS is a simple observational instrument assessing levels of sedation and agitation. It requires no patient input and ranges from +4 (overly combative) to -5 (unarousable). It is considered less time-consuming and easier to use than other similar instruments. Developed for adult intensive care unit patients, the scale demonstrated strong inter-rater reliability in that setting. A modified version was de-signed for use in the palliative care setting, which produced acceptable psychometric properties. Hui et. al. (2018) had caregivers using the RASS to assess patients, which gave ratings similar to clinicians. | 72 hours | |
Secondary | Adverse effects or toxicity, measured by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Possible side effects of taking either drugs are over sedation and extrapyramidal symptoms; these include akathisia, extrapyramidal disorder, and spasticity. To track these adverse events and their severity, the clinician investigator will providing ratings of observed adverse events using the scale provided by the criteria.
Each symptom is scored between 0 (No symptom) to 3 (Severe). |
0-72 hours |
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