UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017438
Receipt number R000020207
Scientific Title A follow-up study of patients at early stage of psychotic disorders
Date of disclosure of the study information 2015/05/07
Last modified on 2019/11/11 16:01:16

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Basic information

Public title

A follow-up study of patients at early stage of psychotic disorders

Acronym

A follow-up study of patients at early stage of psychotic disorders

Scientific Title

A follow-up study of patients at early stage of psychotic disorders

Scientific Title:Acronym

A follow-up study of patients at early stage of psychotic disorders

Region

Japan


Condition

Condition

At-Risk Mental State (ARMS)

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate rate of conversion to psychosis in ARMS individuals

Basic objectives2

Others

Basic objectives -Others

To find risk factors associated with transition to psychosis

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

conversion rate to psychosis based on CAARMS

Key secondary outcomes

demographic features, past treatment history, CAARMS, PANSS, GAF, BDI


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Other

Interventions/Control_1

case-by-case naturalistic treatment (mainly psychosocial therapy, antipsychotic drug therapy)

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

14 years-old <=

Age-upper limit

35 years-old >=

Gender

Male and Female

Key inclusion criteria

Those who met one or more of the ultra-high risk (UHR) criteria using the Comprehensive Assessment of ARMS (CAARMS)

Key exclusion criteria

1) history of previous psychotic disorder or manic episodes that fulfilled the diagnostic criteria of bipolar I disorder; 2) serious risk of suicide or violence due to personality disorder; 3) substance abuse or addiction within 1 year of inclusion; 4) known intellectual disability (IQ < 70); and 5) neurological disorders, head injury, or any other significant medical conditions associated with psychiatric symptoms.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazunori Matsumoto

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Psychiatry

Zip code


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
Middle name
Last name Masahiro Katsura

Organization

Tohoku University Hospital

Division name

Department of Psychiatry

Zip code


Address

1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi

TEL

022-717-7262

Homepage URL


Email

katsura-thk@umin.ac.jp


Sponsor or person

Institute

Department of Psychiatry, Tohoku University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medircal Research and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 05 Month 07 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2008 Year 07 Month 28 Day

Date of IRB

2008 Year 09 Month 10 Day

Anticipated trial start date

2008 Year 09 Month 10 Day

Last follow-up date

2019 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

2015 Year 05 Month 06 Day

Last modified on

2019 Year 11 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020207


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name