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

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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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name