UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062512 |
|---|---|
| Receipt number | R000071536 |
| Scientific Title | A cross-sectional questionnaire survey on psychiatrists' attitudes and practices regarding outpatient initiation of clozapine |
| Date of disclosure of the study information | 2026/08/07 |
| Last modified on | 2026/08/07 15:56:54 |
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Basic information
Public title
A cross-sectional questionnaire survey on psychiatrists' attitudes and practices regarding outpatient initiation of clozapine
Acronym
OCI-JP survey (Outpatient Clozapine Initiation, Japan)
Scientific Title
A cross-sectional questionnaire survey on psychiatrists' attitudes and practices regarding outpatient initiation of clozapine
Scientific Title:Acronym
OCI-JP survey
Region
| Japan |
Condition
Condition
Treatment-resistant schizophrenia; clozapine treatment (study subjects are psychiatrists / society members)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the attitudes, current practices, perceived barriers, conditions for acceptability, and unmet needs of Japanese psychiatric specialists regarding outpatient initiation of clozapine, in order to inform possible revision of the Japanese package insert. This is a descriptive cross-sectional survey without a single hypothesis-testing primary endpoint.
Basic objectives2
Others
Basic objectives -Others
For a survey on attitudes and actual conditions, rather than a verification of efficacy and safety
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of respondents who agree that outpatient initiation of clozapine should be permitted under certain conditions in Japan.
Key secondary outcomes
Consensus classification of system- and policy-level conditions enabling outpatient initiation; intention to adopt outpatient initiation if permitted; proportion and number of patients not initiated because of the inpatient-initiation requirement (unmet need); number of potential candidate patients; importance of prescribing barriers; experience of outpatient continuation after discharge within 18 weeks; preferences regarding the outpatient initiation regimen.
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
| 24 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Member of JSCNP or JSNP; 2) Physician; 3) Understands the purpose of the survey and consents to respond.
Key exclusion criteria
1) Does not meet the inclusion criteria; 2) Judged inappropriate by the principal investigator.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Yoshiteru |
| Middle name | |
| Last name | Takekita |
Organization
Kansai Medical University
Division name
Department of Neuropsychiatry, Faculty of Medicine
Zip code
573-1191
Address
3-1 Shinmachi 2 Chome, Hirakata City, Osaka,
TEL
0728040101
takekita.yos@kmu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiteru |
| Middle name | |
| Last name | Takekita |
Organization
Kansai Medical University
Division name
Department of Neuropsychiatry, Faculty of Medicine
Zip code
573-1191
Address
3-1 Shinmachi 2 Chome, Hirakata City, Osaka
TEL
0728040101
Homepage URL
takekita.yos@kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Yoshiteru Takekita
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Review Board of Kansai Medical University
Address
3-1 Shinmachi 2 Chome, Hirakata City, Osaka
Tel
0728040101
rinri@kmu.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
関西医科大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 07 | 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
Yes. Anonymized, individual-level response data will be publicly shared.
IPD sharing Plan description
Anonymized individual response-level data that cannot identify any individual or institution will be deposited in a public repository (e.g., OSF) at the time of publication and made publicly available with a DOI. A data availability statement with the repository link (DOI) will be included in the published article.
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a non-interventional observational (cross-sectional) study. An anonymous web-based questionnaire (Google Forms) is distributed, through the secretariats of the two societies, to physician members of the Japanese Society of Clinical Neuropsychopharmacology (JSCNP) and the Japanese Society of Neuropsychopharmacology (JSNP). Respondents answer once, at a single time point, without entering any personally or institutionally identifying information. Observed items include respondent and facility background (years of practice, qualifications, society membership, facility type, CPMS registration, emergency coverage, external liaison), clozapine prescribing experience, experience of non-initiation or of withholding a proposal because of the inpatient-initiation requirement, prescribing barriers, attitude toward and intention to adopt outpatient initiation, number of potential candidate patients, conditions that would make outpatient initiation acceptable, and preferences regarding the outpatient initiation regimen. Analyses are primarily descriptive; for the items rated on a 9-point scale (prescribing barriers and acceptability conditions), the mean and 95% confidence interval of each item are calculated to assess the degree of consensus among respondents. This is a descriptive study without a single hypothesis-testing primary endpoint.
Management information
Registered date
| 2026 | Year | 08 | Month | 07 | Day |
Last modified on
| 2026 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071536
