UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045925 |
|---|---|
| Receipt number | R000052417 |
| Scientific Title | Real-world effectiveness of antipsychotic treatments in acutely hospitalized patients with schizophrenia: multi-center prospective observational study |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2023/08/31 14:48:20 |
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Basic information
Public title
Real-world effectiveness of antipsychotic treatments in acutely hospitalized patients with schizophrenia: multi-center prospective observational study
Acronym
Real-world effectiveness of antipsychotic treatments
Scientific Title
Real-world effectiveness of antipsychotic treatments in acutely hospitalized patients with schizophrenia: multi-center prospective observational study
Scientific Title:Acronym
Real-world effectiveness of antipsychotic treatments
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the real-world effectiveness of antipsychotic treatments focusing on long-acting injectable antipsychotic medications (LAIs) and antipsychotic polytherapies except polytherapy involving clozapine (APEC) for patients with schizophrenia.
Basic objectives2
Others
Basic objectives -Others
Patients included in RCTs represent a minority of the patient population. Although the strength of observational studies using nationwide databases is that there are no missing data on rehospitalization or treatment failure (Tiihonen et al. 2017), such databases do not include information on clinical characteristics such as symptoms, illness severity, and non-adherence. To overcome this problem, a multicenter, prospective, cohort study in which acutely admitted patients with schizophrenia-spectrum disorders are followed-up is conducted. The objective of the study is to determine the effectiveness of antipsychotic treatments focusing on LAIs and antipsychotic polytherapy for the prevention of treatment failure in patients with schizophrenia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk of treatment failure defined as psychiatric rehospitalization, discontinuation of medication, suicide, and death
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Schizophrenia and Other Psychotic Disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
2) Patients who do not refuse to participate (opt out)
3) Patients are newly admitted to psychiatric emergency wards because of acute onset or exacerbation
Key exclusion criteria
Diagnosis other than 1)
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Hatta |
Organization
Juntendo University Nerima Hospital
Division name
Department of Psychiatry
Zip code
177-8521
Address
Takanodai 3-1-10, Nerima-ku, Tokyo 177-8521, Japan
TEL
03-5923-3111
khatta@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Hatta |
Organization
Juntendo University Nerima Hospital
Division name
Department of Psychiatry
Zip code
177-8521
Address
Takanodai 3-1-10, Nerima-ku, Tokyo 177-8521, Japan
TEL
03-5923-3111
Homepage URL
khatta@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Japanese Association for Emergency Psychiatry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Faculty of Medicine, IRB
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.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
沼津中央病院（静岡県），旭川圭泉会病院（北海道），土佐病院（高知県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 31 | 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
481
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Enrollment: April,2022-March,2023; Follow-up:-March,2026
2. multi-center, prospective observational design
3. Patients are newly admitted to psychiatric emergency wards because of acute onset or exacerbation of Schizophrenia. The primary outcome is the risk of treatment failure defined as psychiatric rehospitalization, discontinuation of medication, suicide, or death for 3 years.
Management information
Registered date
| 2021 | Year | 10 | Month | 29 | Day |
Last modified on
| 2023 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052417
