UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034764
Receipt No. R000039138
Official scientific title of the study 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 2018/11/05

* 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
Official scientific title of the study Development of clinical indicators useful for clarifying the pathology of early psychosis and predicting prognosis
Title of the study (Brief title) 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
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 Kazunori Matsumoto
Organization Tohoku University Graduate School of Medicine
Division name Department of Psychiatry
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 022-717-7262
Email kaz-mat@umin.net

Public contact
Name of contact person Yutaro Sato
Organization Tohoku University Graduate School of Medicine
Division name Department of Psychiatry
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 022-717-7262
Homepage URL
Email a6mb1043-thk@umin.ac.jp

Sponsor
Institute Department of Psychiatry, Tohoku University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 24 Day
Anticipated trial start date
2018 Year 12 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 05 Day
Last modified on
2018 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039138

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.