NCT05431595 Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy
| NCT ID | NCT05431595 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2022-07-19 |
| Primary Completion | 2027-02-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 42 participants in total. It began in 2022-07-19 with a primary completion date of 2027-02-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To examine the effects of haloperidol, chlorpromazine, valproic acid and placebo, in conjunction with standardized non-pharmacologic interventions, in the first line treatment of agitated delirium in hospitalized patients with cancer. This double-blind, randomized clinical trial aims to provide evidence on various therapeutic options for palliating delirium, thereby reducing delirium-related distress and ultimately alleviating suffering.
Eligibility Criteria
Inclusion Criteria: 1. \[Patients\] Diagnosis of advanced cancer (defined as locally advanced, metastatic recurrent, or incurable disease) 2. \[Patients\] Seen by palliative care inpatient consultation team 3. \[Patients\] Delirium as per DSM-5 criteria 4. \[Patients\] Hyperactive or mixed delirium with either a rescue medication order or any non-pharmacologic measures (e.g. sitter, restraints) for agitation, restlessness, or delirium 5. \[Patients\] Age 18 years or older 6. \[Patients\] Permission from clinician from primary team to enroll 7. \[Family Caregivers\] Patient's spouse, adult child, sibling, parent, other relative, or significant other (defined by the patient as a partner) 8. \[Family Caregivers\] Age 18 years or older Exclusion Criteria: 1. \[Patients\] On scheduled haloperidol \>4 mg/d, chlorpromazine \>100 mg/d, or valproate \>750 mg/d 2. \[Patients\] History of myasthenia gravis, acute narrow-angle glaucoma, or hepatic encephalopathy as documented in chart 3. \[Patients\] Hepatic dysfunction (unresolved AST or ALT \>2.5x ULN, bilirubin \>1.5x ULN or INR \>1.5 within past month) 4. \[Patients\] History of neuroleptic malignant syndrome as documented in chart 5. \[Patients\] Active seizure disorder within past month as documented in chart 6. \[Patients\] History of Parkinson's disease or dementia as documented in chart 7. \[Patients\] History of prolonged QTc interval (\>500 ms) if documented by most recent ECG within the past month 8. \[Patients\] Hypersensitivity to haloperidol, chlorpromazine, or valproate as documented in chart 9. \[Patients\] Pancreatitis within past month as documented in chart 10. \[Patients\] Currently on lamotrigine, phenobarbital, or carbamazepine 11. \[Patients\] Physical signs of impending death such as respiration with mandibular movement and death rattle 12. \[Patients\] Pregnancy as documented in chart 13. \[Patients\] Active COVID-19 infection as documented in chart
Contact & Investigator
David Hui, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT05431595 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05431595 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05431595 currently recruiting?
Yes, NCT05431595 is actively recruiting participants. Contact the research team at dhui@mdanderson.org for enrollment information.
Where is the NCT05431595 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05431595 clinical trial?
NCT05431595 is sponsored by M.D. Anderson Cancer Center. The principal investigator is David Hui, MD at M.D. Anderson Cancer Center. The trial plans to enroll 42 participants.