Tokyo, Feb. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060648) titled 'Study on the safety and efficacy of different application methods (intermittent vs 24-hour) of blonanserin patch in hospitalized patients' on Feb. 11.
Study Type:
Observational
Primary Sponsor:
Institute - Kyoto University
Condition:
Condition - Delirium
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify whether the intermittent application (night-time only) of blonanserin transdermal patches avoids daytime over-sedation (safety) compared to conventional 24-hour continuous application, and to assess whether it maintains efficacy in treating or preventing delirium recurrence in hospitalized patients, through a retrospective chart review.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 65
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Inpatients at Kyoto University Hospital (from January 1, 2020, to December 31, 2024).
2. Aged 65 years or older.
3. Patients who started blonanserin transdermal patches for either prevention or treatment of delirium.
Key exclusion criteria - Patients who were already receiving regular administration of antipsychotics or high-potency sedatives at the time of admission.
Target Size - 140
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 05 Day
Date of IRB - 2025 Year 12 Month 02 Day
Anticipated trial start date - 2026 Year 02 Month 11 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069154
Disclaimer: Curated by HT Syndication.
