UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034764 |
|---|---|
| Receipt number | R000039138 |
| Scientific Title | Development of clinical indicators useful for clarifying the pathology of early psychosis and predicting prognosis |
| Date of disclosure of the study information | 2018/11/05 |
| Last modified on | 2020/05/12 09:09:29 |
* 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
Development of clinical indicators useful for clarifying the pathology of early psychosis and predicting prognosis
Acronym
Development of clinical indicators useful for clarifying the pathology of early psychosis and predicting prognosis
Scientific Title
Development of clinical indicators useful for clarifying the pathology of early psychosis and predicting prognosis
Scientific Title:Acronym
Development of clinical indicators useful for clarifying the pathology of early psychosis and predicting prognosis
Region
| Japan |
Condition
Condition
At-Risk Mental State (ARMS)
First Episode Psychosis
Classification by specialty
| Psychiatry | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarifying pathology of psychosis and developing clinical indicators useful for predicting prognosis of early psychosis
Basic objectives2
Others
Basic objectives -Others
To evaluate clinical indicators such as childhood trauma, brain structure and hippocampal glutamate abnormalities in individuals at risk mental state, individuals with first episode psychosis and healthy control, and investigate the relationship with clinical stage and prognosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
GAF
Global Function
transition to psychosis
Key secondary outcomes
whole-brain gray matter volume, whole-brain white matter volume
metabolic level in hippocampus
CTQ, CAARMS, PANSS, PSYRATS-J, JCDSS, BDI-II, PCL, AQ-J, LSAS, QPR-J, BACS, WCST, CBQp
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Magnetic Resonance Imaging (MRI)
Magnetic Resonance Spectroscopy (MRS)
Interventions/Control_2
Magnetic Resonance Imaging (MRI)
Magnetic Resonance Spectroscopy (MRS)
Interventions/Control_3
Magnetic Resonance Imaging (MRI)
Magnetic Resonance Spectroscopy (MRS)
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
| 14 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
at risk mental state (ARMS)
A) Those who meet ARMS criteria at the PACE clinic
B) Within two years after first meeting ARMS criteria
C) no history of psychosis that meet psychosis criteria at PACE clinic
D) age 14-39 years
E) native Japanese speaker
F) Those who have no decline in judgment ability by psychotic symptoms and obtain written informed consent to this study by themselves (in the case of minors, even from person in parental authority)
first episode psychosis (FEP)
A) Those who meet criteria of the DSM-IV for schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder,psychotic disorder not otherwise specified, major depressive disorder with psychotic features, or bipolar disorder with psychotic features; confirmed by the Mini International Neuropsychiatric Interview (MINI)
B) Within two years after first diagnosis of psychosis
C) age 14-39 years
D) native Japanese speaker
E) Those who have no decline in judgment ability by psychotic symptoms and obtain written informed consent to this study by themselves (in the case of minors, even from person in parental authority)
healthy control
A) Those who have no history of mental disorders and do not correspond to mental disorder in MINI
B) age 14-39 years
C) native Japanese speaker
D) Those who have no decline in judgment ability by psychotic symptoms and obtain written informed consent to this study by themselves (in the case of minors, even from person in parental authority)
Key exclusion criteria
A) history of neurological disorders, head injury, or any other significant medical condition associated with psychiatric symptoms
B) substance use disorder
C) intellectual disability
D) exclusion criteria to MRI: presence of a pacemaker, metallic implants, claustrophobia (exclusion criteria for only the research part related to MRI)
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Matsumoto |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
9808574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7262
kaz-mat@umin.net
Public contact
Name of contact person
| 1st name | Yutaro |
| Middle name | |
| Last name | Sato |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
9808574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7262
Homepage URL
a6mb1043-thk@umin.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Hospital
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-717-7262
hosp-ken@grp.tohoku.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
| 2018 | Year | 11 | Month | 05 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 05 | Day |
Last modified on
| 2020 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039138
