UMIN-CTR Clinical Trial

Basic information
Public title	A comprehensive research on identifying factors to predict transition to psychosis in participants at At-Risk Mental State by using Rorschach profiles and stress-related biomarkers in saliva.
Acronym	Predictive factors for transition to psychosis in ARMS subjects
Scientific Title	A comprehensive research on identifying factors to predict transition to psychosis in participants at At-Risk Mental State by using Rorschach profiles and stress-related biomarkers in saliva.
Scientific Title:Acronym	Predictive factors for transition to psychosis in ARMS subjects
Region	Japan

Condition
Condition	schizophrenia, At-Risk Mental State
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective is to explore predictive biomarkers in At Risk Mental State (ARMS) subjects during transition to psychosis, focusing on changes in psychological characteristics and changes in stress-related biomarkers in saliva.
Basic objectives2	Others
Basic objectives -Others	Comparison of Rorschach profiles and biomarkers between ARMS subjects, schizophrenia subjects and healthy controls.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	(a)Rorschach test (b)Structured Interview for Prodromal Syndromes: SIPS (c)The Scale of Prodromal Symptoms: SOPS (d)Cortisol in saliva 2ml: alpha-Amylase, CRP (C-Reactive Protein), IL-6, IL-1-beta, in saliva.
Key secondary outcomes	(a)the Scale to Assess Unawareness of Mental Disorder Japanese Version: SUMD-J (b)Subjective Well-being under Neuroleptic drug treatment Short form, Japanese version: SWNS-J (c)Positive and Negative Syndrome Scale: PANSS (d)The Brief Assessment of Cognition in Schizophrenia: BACS (e)Beck Depression Inventory-2: BDI-2 (f)Height, weight, smoking status

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	15 years-old <=
Age-upper limit	40 years-old >=
Gender	Male and Female
Key inclusion criteria	Basic standards 1)Provide consent to sample bioinformation, capable and willing to follow the research process. 2)Age between 15 to 40 3)Total IQ higher than or equal to 70 UHR group 1)Meet at least one out of the three types of symptomatology as below (You should be aware that the three types of prodromal symptoms are not mutually exclusive. A patient may fulfill more than one type of symptomatology). The Criteria of Prodromal Syndromes: COPS A)Brief Intermittent Psychotic Syndromes: BIPS B)Attenuated Positive Symptom Syndrome: APSS C)Genetic Risk and Deterioration Syndrome: GRDS Health Controls 1)Healthy controls, who were age and sex matched with UHR group.
Key exclusion criteria	1)Those who have neurologic or medical neurologic or medical conditions as below: history of head trauma with loss of consciousness, chronic pulmonary disease, kidney disease, chronic liver disease, thyroid disease, active cancer, cerebrovascular disease, epilepsy, neurological disorder, substance related disorder, or mental retardation(IQ<70), obvious history of psychosis. 2)Those who are not seeking for help. 3)Those who suffer from autoimmune disease (SLE, hyperthyroidism: Graves' disease, ulcerative colitis, Crohn's disease). 4)Regular use of steroid or NSAID. 5)The attending physician decided that the patient was inappropriate to participate in the study.
Target sample size	168

Research contact person
Name of lead principal investigator	1st name Tsubasa Middle name Last name Morimoto
Organization	Nara Medical University
Division name	Department of Psychiatry Psychiatric Institute
Zip code	6348522
Address	840 Shijocho Kashihara Nara
TEL	+81-744-22-3051
Email	tsubasa@naramed-u.ac.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name Kishimoto
Organization	Nara Medical University
Division name	Department of Psychiatry Psychiatric Institute
Zip code	6348522
Address	840 Shijocho Kashihara Nara
TEL	+81-744-22-3051
Homepage URL
Email	naoko@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
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	Nara Medical University
Address	840 Shijocho Kashihara Nara
Tel	+81-744-22-3051
Email	naoko@naramed-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

Other administrative information
Date of disclosure of the study information	2019 Year 11 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	Open public recruiting
Date of protocol fixation	2019 Year 04 Month 24 Day
Date of IRB	2019 Year 08 Month 21 Day
Anticipated trial start date	2019 Year 08 Month 21 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	nothing special

Management information
Registered date	2019 Year 11 Month 13 Day
Last modified on	2019 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043959