UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060648 |
|---|---|
| Receipt number | R000069154 |
| Scientific Title | Retrospective comparative observational study on the effects of intermittent versus 24-hour application of blonanserin transdermal patches on delirium events and daytime over-sedation in hospitalized patients |
| Date of disclosure of the study information | 2026/02/11 |
| Last modified on | 2026/02/11 01:35:19 |
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Basic information
Public title
Study on the safety and efficacy of different application methods (intermittent vs 24-hour) of blonanserin patch in hospitalized patients
Acronym
Observational study on blonanserin patch application
Scientific Title
Retrospective comparative observational study on the effects of intermittent versus 24-hour application of blonanserin transdermal patches on delirium events and daytime over-sedation in hospitalized patients
Scientific Title:Acronym
Comparative study of intermittent vs 24-hour blonanserin patch
Region
| Japan |
Condition
Condition
Delirium
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of daytime over-sedation during the first 3 days after initiation (percentage of patients with at least one record of RASS -2 or lower based on nursing records or RASS scores between 8:00 and 21:00).
Key secondary outcomes
1. Delirium cure rate at Day 2 (in the cohort with delirium).
2. Delirium incidence/recurrence rate by Day 2 (in the cohort without delirium).
3. Rate of change or discontinuation of the application strategy.
4. Rate of new addition or dose increase of other psychotropics or sedatives.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Yudai |
| Middle name | |
| Last name | Takatani |
Organization
Kyoto University Hospital
Division name
Department of Primary Care and Emergency Medicine
Zip code
606-8507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-4210
takataniyu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yudai |
| Middle name | |
| Last name | Takatani |
Organization
Kyoto University Hospital
Division name
Department of Primary Care and Emergency Medicine
Zip code
606-8507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-4210
Homepage URL
takataniyu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Foundation for Promotion of Education and Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Kyoto University Graduate School and Faculty of Medicine, Kyoto University Hospital
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
Tel
075-751-4748
ctsodan@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design, Subject Recruitment, and Measured Items
Study Design:
This is a single-center, retrospective cohort study covering the period from 2020 to 2024.
Subject Recruitment:
The study subjects are patients admitted to all departments of Kyoto University Hospital between January 1, 2020, and December 31, 2024. Cases meeting the following criteria will be identified and extracted from electronic health records based on medication prescription data and clinical notes:
Inclusion Criteria: (1) Age 65 years or older; (2) Patients who were started on blonanserin transdermal patch (Lonasen Tape) for either the prevention or treatment of delirium.
Exclusion Criteria: Patients who were already receiving regular administration of antipsychotics or high-potency sedatives at the time of admission.
Measured Items:
The primary outcomes are the incidence of daytime oversedation (based on RASS scores or clinical descriptions of somnolence) and delirium events (recovery, occurrence, or recurrence) during the first three days (Day 0 to Day 2) after initiation. Baseline information to be collected includes age, sex, presence of dementia, pre-admission use of antipsychotics or sedatives, prescribed dose of blonanserin patch, and the primary application strategy (intermittent or 24-hour application). Safety-related data, including creatine kinase (CK), AST, ALT, white blood cell count, and CRP levels, as well as the occurrence of serious adverse events (e.g., falls, seizures, malignant syndrome), will also be collected from clinical records.
Management information
Registered date
| 2026 | Year | 02 | Month | 11 | Day |
Last modified on
| 2026 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069154
