UMIN-CTR Clinical Trial

Basic information
Public title	Development and validation of a clinical prediction model for psychotic relapse within 12 months after discharge in people with schizophrenia
Acronym	Development and validation of a clinical prediction model for psychotic relapse within 12 months after discharge in people with schizophrenia
Scientific Title	Development and validation of a clinical prediction model for psychotic relapse within 12 months after discharge in people with schizophrenia
Scientific Title:Acronym	Development and validation of a clinical prediction model for psychotic relapse within 12 months after discharge in people with schizophrenia
Region	Japan

Condition
Condition	Schizophrenia and related disorders
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop and validate a clinical prediction model for psychotic relapse within 12 months after discharge in people with schizophrenia and related disorders who are aged 18 years or older, by retrospectively collecting pre-specified prognostic factors by chart review in five urban and rural hospitals.
Basic objectives2	Others
Basic objectives -Others	This study aims to build a prediction model and validate its accuracy and generalisability.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Psychotic relapse as a composite outcome defined by an occurrence of any one of the following: psychiatric hospitalisation, psychiatrist's decision that hospitalisation is required, an increase in antipsychotic dosage, an increase in the level of psychiatric care, and violence to self and/or others. Participants will be followed up up to 12 months after their discharge from the index hospitalisation.
Key secondary outcomes	Psychiatric hospitalisation due to psychotic relapse

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 who were discharged from one of five participating hospitals between January 2014 and December 2018 will be included if they were diagnosed as one of the following (ICD-10 code in the parentheses): - Schizophrenia (F20) - Schizotypal disorder (F21) - Persistent delusional disorders (F22) - Acute and transient psychotic disorders (F23) - Induced delusional disorder (F24) - Schizoaffective disorders (F25) - Other nonorganic psychotic disorders (F28) - Unspecified nonorganic psychosis (F29)
Key exclusion criteria	Patients with the following conditions will be excluded: - Those who had been enrolled in this study with a previous episode of hospitalisation due to psychosis (i.e. a patient cannot be enrolled more than once during the study period) - Those with substance/medication-induced psychosis - Those with psychosis due to another medical condition, including peri-and postpartum psychosis and psychosis in dementia - Those with diagnosis in the inclusion criteria with which one of investigators disagree due to the lack of sound reasoning - Those discharged from a non-acute ward - Those with a plan to be readmitted in the short period of time - Those with ambiguous diagnosis as judged by one of investigators - Those discharged to another psychiatric hospital - Those discharged to medical hospital
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Toshiaki Middle name A Last name Furukawa
Organization	Kyoto University Graduate School of Medicine / School of Public Health
Division name	Department of Health Promotion and Human Behavior
Zip code	606-8501
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL	075-753-9491
Email	furukawa@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Sato
Organization	Kyoto University School of Medicine
Division name	Department of Health Promotion and Human Behavior
Zip code	606-8501
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL	080-3475-7068
Homepage URL
Email	sato.akira.57m@st.kyoto-u.ac.jp

Sponsor
Institute	Department of Health Promotion and Human Behavior, Kyoto University School of Medicine
Institute
Department

Funding Source
Organization	self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Isogaya Hospital Iwate Prefecture Nanko Hospital Urawa Shinkei Sanatorium Chiba Psychiatric Medical Centre Tsukuba University Wakamiya Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel	075-753-4680
Email	ethcom@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	医療法人直樹会　磯ヶ谷病院(千葉県)、岩手県立南光病院(岩手県)、医療法人白翔会　浦和神経サナトリウム(埼玉県)、千葉県精神科医療センター(千葉県)、筑波大学(茨城県）、医療法人公徳会　若宮病院(山形県)

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 20 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	2020 Year 12 Month 15 Day
Date of IRB	2020 Year 12 Month 21 Day
Anticipated trial start date	2020 Year 12 Month 22 Day
Last follow-up date	2023 Year 05 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Participants who discharged between 1 January 2014 and 31 December 2018 will be consecutively included in accordance with the eligibility criteria. In order to pre-specify predictors from previous studies, we searched Ovid Medline on 3 September 2020. From 3490 records that were initially identified, 189 articles were included. By counting the numbers of predictors in the articles, 8 predictors that were counted more than 10 times were pre-selected, along with other four predictors that were thought to be clinically important through a discussion of our research team. Pre-selected predictors that will be collected by chart review are: - Age at discharge - Sex - Number of past psychiatric hospitalisations - Presence of psychiatric hospitalisation last year - Current length of stay - Presence of substance use disorder - Number of Psychosocial interventions - Use of long acting injections - Presence of metabolic syndrome - Body-mass index (BMI) - Presence of current smoking - Receipt of beneficiary. Missing data will be imputed by multiple imputation. Statistical analyses will be performed with R (version 3.6.0). Multivariable regression analyses will be conducted, and estimated coefficients for each predictor will be penalised using shrinkage methods such as LASSO to avoid overfitting. Model's discrimination and calibration abilities will be evaluated. Internal validity and internal-external validity will be evaluated using, for example, leave-one-patient-out cross-validation and leave-one-site-out cross-validation, respectively. Modelling with machine learning such as random forest will also be evaluated for exploratory purposes. Web application will be implemented with Shiny package in R to visually present the developed and validated prediction model for consumers, their families, and mental health professionals. The study will be reported in accordance with the TRIPOD recommendations.

Management information
Registered date	2021 Year 02 Month 16 Day
Last modified on	2021 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049467

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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