UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053318 |
|---|---|
| Receipt number | R000060859 |
| Scientific Title | A Multi-center Intervention Study on the Usefulness of Single Group Psychoeducational Session for Patients Using the "Guide for Pharmacological Therapy of Schizophrenia 2022" |
| Date of disclosure of the study information | 2024/01/15 |
| Last modified on | 2024/01/10 23:35:25 |
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Basic information
Public title
The usefulness of psychoeducation for patients using the Guide for Pharmacological Therapy of Schizophrenia 2022 (UKE-KOTSU) study
Acronym
Psychoeducation using the Guide for Pharmacological Therapy of Schizophrenia (UKE-KOTSU) Study
Scientific Title
A Multi-center Intervention Study on the Usefulness of Single Group Psychoeducational Session for Patients Using the "Guide for Pharmacological Therapy of Schizophrenia 2022"
Scientific Title:Acronym
Psychoeducation using the Guide for Pharmacological Therapy of Schizophrenia (UKE-KOTSU) Study
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Group psychoeducation for schizophrenia patients will be conducted using the "Guide for Pharmacological Therapy of Schizophrenia 2022" to examine changes in knowledge of the illness and the effects on mid- to long-term medical adherance and their qulity of life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in Knowledge of Medication for Schizophrenia Before and After Psychoeducation
Key secondary outcomes
Changes in the level of practice of receiving treatment using the Guide and attitude toward medications before the implementation of psychoeducation and every 6 months up to 18 months thereafter. Changes in patients' Quality Of Life from before psychoeducation up to 5 years every 6 months thereafter.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A 60-minute single group psychoeducational session using the "Guide for pharmacological therapy of Schizophrenia 2022"
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 who are judged by their attending psychiatrist to meet the diagnostic criteria for schizophrenia according to the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition).
- Persons who are judged by the attending psychiatrist to be eligible to participate in the study.
- Age 18 years or older at the time consent is obtained.
- Those who have given written consent to participate in the study.
Key exclusion criteria
- Persons with comorbid dementia
- Persons whose psychiatric symptoms are considered to be affected by substances or other medical conditions
- Other persons deemed unsuitable by the principal investigator or principal investigator-in-charge.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Kayo |
| Middle name | |
| Last name | Ichihashi |
Organization
University of Tokyo Hospital
Division name
Department of Neuropsychiatry
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-9263
ichihashi-ymh@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kayo |
| Middle name | |
| Last name | Ichihashi |
Organization
University of Tokyo Hospital
Division name
Department of Neuropsychiatry
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-9263
Homepage URL
ichihashi-ymh@umin.ac.jp
Sponsor or person
Institute
University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development; AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2031 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060859
