UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038573 |
|---|---|
| Receipt number | R000043959 |
| 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. |
| Date of disclosure of the study information | 2019/11/15 |
| Last modified on | 2019/11/13 21:35:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
naoko@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043959
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
