Preventive effect of active Potocol-Based Pharmacotherapy Management for delirium

Preventive effect of active Protocol-Based Pharmacotherapy Management for delirium in general wards of emergency department: A Single-Center, Randomized Controlled Trial - aPBPM trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051220122

Enrollment

105

Registered

2022-11-25

Start date

2022-11-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Interventions

(When oral administration is impossible) Blonanserin

apply 8mg to the skin daily from 19:00 to 6:00 the next morning for 3 days. If insomnia does not improve, increase the dose to 40mg the next day or later. (When oral administration is possible) Ramel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who are admitted to the general ward of the department of primary care and emergency medicine from the emergency room. 2) One or more of the following six risk factors for developing delirium: central nervous system disease, cognitive dysfunction, history of high alcohol intake, history of delirium, use of drugs at risk of delirium, Post-surgery or scheduled surgery requiring general anesthesia. 3) Patients over 65 years old.

Exclusion criteria

Exclusion criteria: 1) Patients with schizophrenia 2) Patients taking antipsychotics. 3) Patients who cannot be hospitalized for more than48 hours. 4) Patients taking benzodiazepines prescribed by a psychiatrist or psychosomatic physician 5) Patients taking CYP3A4 inhibitors (itraconazole, clarithromycin, erythromycin, fluconazole, verapamil, HIV protease inhibitor, etc.) 6) Patients taking Ramelteon or lemborexant 7) Blonanserin patch is applied 8) Patients with severe liver dysfunction 9) Patients with severe disturbance of consciousness 10) Sedatives are used before the start of the study 11) Patients with drug abuse

Design outcomes

Primary

Measure	Time frame
Incidence of delirium diagnosed with DSM-5 within 3 days of the start of the study	—

Secondary

Measure	Time frame
Cumulative incidence of delirium within 3 days of the start of the study, Incidence of delirium diagnosed with DSM-5 by study drug within 3 days of the start of the study, Total score (worst value for 3 days) of DRS-R98-J (Japanese version of the delirium Rating Scale, Revised-98), Severity score (worst value for 3 days) of DRS-R98-J, Score for item 1 of DRS-R98-J, "Sleep-wake cycle disturbance", Total dose of rescue drug hydroxyzine, Incidence of restlessness within 3 days of the start of the study, Incidence of restlessness and agitation associated with dementia within 3 days of the start of the study	—

Measure

Time frame

Cumulative incidence of delirium within 3 days of the start of the study, Incidence of delirium diagnosed with DSM-5 by study drug within 3 days of the start of the study, Total score (worst value for 3 days) of DRS-R98-J (Japanese version of the delirium Rating Scale, Revised-98), Severity score (worst value for 3 days) of DRS-R98-J, Score for item 1 of DRS-R98-J, "Sleep-wake cycle disturbance", Total dose of rescue drug hydroxyzine, Incidence of restlessness within 3 days of the start of the study, Incidence of restlessness and agitation associated with dementia within 3 days of the start of the study

—

Contacts

Public ContactYudai Takatani

Kyoto University Hospital

takataniyu@kuhp.kyoto-u.ac.jp+81-75-751-4210

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026