Mental and Behavioural Disorders
Conditions
Interventions
Lurasidone
Haloperidol
Sponsors
Mansoura University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients were eligible for inclusion if they met all the following criteria: 1.? ?Age between 18 and 80 years. 2.? ?Admitted to the ICU for any medical or surgical cause. 3.? ?Diagnosed with delirium or psychosis according to DSM-5 criteria, confirmed by a positive CAM-ICU assessment . 4.? ?Expected ICU stay = 72 hours. 5.? ?Informed consent obtained from the patient or legally authorized representative.
Exclusion criteria
Exclusion criteria: Patients were excluded if any of the following applied: 1.? ?Known hypersensitivity to haloperidol or lurasidone. 2.? ?Preexisting major neurological or psychiatric disorders (e.g., Parkinson’s disease, schizophrenia). 3.? ?Severe hepatic impairment (Child–Pugh class C) or renal failure requiring dialysis. 4.? ?Baseline QTc>470 ms or concurrent use of QT-prolonging medications. 5.? ?Pregnancy or lactation. 6.? ?Coma, deep sedation, or inability to assess delirium clinicallyation of Helsinki.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resolution of ICU delirium during the treatment period, assessed by a validated delirium assessment tool and comparison of response between haloperidol and lurasidone groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to resolution of delirium symptoms in each treatment group.;Length of ICU stay.;All-cause ICU mortality during the study period.;Incidence of adverse drug effects, including extrapyramidal symptoms, excessive sedation, QTc prolongation, arrhythmias, and hemodynamic instability.;Need for rescue sedation or additional antipsychotic medication during ICU stay. | — |
Countries
Egypt
Contacts
Public ContactAlaaedin Eldeeb
Professor of anesthesia and intensive care
Outcome results
None listed