UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063158 |
|---|---|
| Receipt number | R000072290 |
| Scientific Title | Preference Study for Schizophrenia Treatment Among Patients, Caregivers, and Physicians: A Discrete Choice Experiment |
| Date of disclosure of the study information | 2026/10/05 |
| Last modified on | 2026/10/03 14:28:45 |
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Basic information
Public title
Preference Study for Schizophrenia Treatment Among Patients, Caregivers, and Physicians: A Discrete Choice Experiment
Acronym
Preference Study for Schizophrenia Treatment Among Patients, Caregivers, and Physicians: A Discrete Choice Experiment
Scientific Title
Preference Study for Schizophrenia Treatment Among Patients, Caregivers, and Physicians: A Discrete Choice Experiment
Scientific Title:Acronym
Preference Study for Schizophrenia Treatment Among Patients, Caregivers, and Physicians: A Discrete Choice Experiment
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the preference structures and relative importance of treatment attributes among patients with schizophrenia, their caregivers, and physicians.
Basic objectives2
Others
Basic objectives -Others
To identify the treatment attributes that are most important to patients with schizophrenia, caregivers, and physicians, and to assess the trade-offs between efficacy, safety, and other treatment-related attributes in schizophrenia treatment.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Preferences for, and relative importance of, multiple treatment attributes associated with schizophrenia treatment
Key secondary outcomes
Trade-offs Between Convenience Gains Associated with Treatment Changes and Other Treatment Attributes in Schizophrenia Treatment
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients
1.Provide informed consent and agree to participate in the study.
2.Be aged 18 years or older at the time of survey completion.
3.Have received a diagnosis of schizophrenia from a physician.
4.Have been receiving treatment for schizophrenia for at least 1 year prior to participation.
5.Be currently receiving pharmacological treatment for schizophrenia.
Caregivers
1.Provide informed consent and agree to participate in the study.
2.Be aged 18 years or older at the time of survey completion.
3.Not have a diagnosis of schizophrenia.
4.Reside with the care recipient.
5.Be the primary caregiver of a patient with schizophrenia and not provide regular caregiving to any other individual.
6.Provide care for a patient with schizophrenia who is aged 18 years or older.
7.Provide care for a patient with schizophrenia who has been receiving treatment for at least 1 year.
8.Provide care for a patient with schizophrenia who is currently receiving pharmacological treatment.
Physicians
1.Provide informed consent and agree to participate in the study.
2.Be a hospital-based physician or a physician in private practice.
3.Currently provide clinical care for at least 20 patients with schizophrenia per month.
Key exclusion criteria
Patients
1.Patients who have been hospitalized due to worsening symptoms within the past 3 months.
2.Patients with comorbid depression, bipolar disorder, epilepsy, or dementia.
Caregivers
1.Caregivers whose care recipient has been hospitalized due to worsening symptoms within the past 3 months.
2.Caregivers whose care recipient has comorbid depression, bipolar disorder, epilepsy, or dementia.
Physicians
1.Physicians who are currently involved in a clinical trial for schizophrenia.
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Kondo |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Department of Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Kondo.Tomohiro.a@otsuka.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Kondo |
Organization
Otsuka Pharmaceuticals Co., Ltd
Division name
Department of Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Homepage URL
Kondo.Tomohiro.a@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation TOUKEIKAI Kitamachi Clinic IRB
Address
1-1-3,Kichijoji-kitamachi,Musashino-shi,Tokyo,180-0001,Japan, Tokyo
Tel
03-6779-8166
chi-pr-cirb-kitamachi@cmicgroup.com
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To identify the preference structures and relative importance of treatment attributes among patients with schizophrenia, their caregivers, and physicians.
Management information
Registered date
| 2026 | Year | 10 | Month | 03 | Day |
Last modified on
| 2026 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072290
