UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008660
Receipt number R000006204
Scientific Title A research of exploring possible predictive biomarkers for remission and recovery in ultra-high-risk individuals and first-episode psychosis
Date of disclosure of the study information 2012/08/10
Last modified on 2023/08/18 09:12:41

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Basic information

Public title

A research of exploring possible predictive biomarkers for remission and recovery in ultra-high-risk individuals and first-episode psychosis

Acronym

Integrative Neuroimaging studies in Schizophrenia Targetting for Early intervention and Prevention (IN-STEP) project.

Scientific Title

A research of exploring possible predictive biomarkers for remission and recovery in ultra-high-risk individuals and first-episode psychosis

Scientific Title:Acronym

Integrative Neuroimaging studies in Schizophrenia Targetting for Early intervention and Prevention (IN-STEP) project.

Region

Japan


Condition

Condition

Ultra-high-risk for psychosis (UHR) and first-episode psychosis (FEP).

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To investigate possible predictive biomarkers for transition to psychosis, symptomatic remission, and social recovery, which are useful in clinical settings.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The rate of transition to psychosis.

Key secondary outcomes

The rate of symptomatic remission and social recovery.


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

12 years-old <=

Age-upper limit

40 years-old >=

Gender

Male and Female

Key inclusion criteria

1. No history of antipsychotic drug treatments for more than 16 cumulative weeks
2. Continuous psychotic symptoms within the past 60 months

Key exclusion criteria

1. More than 31 years old in UHR group
2. Neurological illness
3. Previous traumatic brain injury with any known cognitive consequences or loss of consciousness for more than 5 min
4. A history of electroconvulsive therapy
5. Low premorbid IQ (below 70)
6. Previous alcohol addiction
7. Previous continuous substance use
8. Clearly diagnosed with autistic disorder according to the DSM-IV criteria

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Kiyoto
Middle name
Last name Kasai

Organization

The University of Tokyo

Division name

Department of Neuropsychiatry, Graduate School of Medicine

Zip code

113-8655

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

+81-3-5800-9263

Email

skoike-tky@umin.ac.jp


Public contact

Name of contact person

1st name Shinsuke
Middle name
Last name Koike

Organization

The University of Tokyo

Division name

Department of Neuropsychiatry, Graduate School of Medicine

Zip code

113-8655

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

+81-3-5800-9263

Homepage URL

http://plaza.umin.ac.jp/arms-ut/

Email

skoike-tky@umin.ac.jp


Sponsor or person

Institute

Department of Neuropsychiatry, Graduate School of Medicine, the University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

AMED, JSPS

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)

Grants from the JSPS/MEXT
Grants from the Strategic Research Program for Brain Sciences by the MEXT
Grants from the Japan Research Foundation for clinical Pharmacology


IRB Contact (For public release)

Organization

Ethics Committee, Faculty of Medicine, The University of Tokyo

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

Tel

070-1394-7637

Email

ethics@m.u-tokyo.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

東京大学医学部付属病院(東京都)


Other administrative information

Date of disclosure of the study information

2012 Year 08 Month 10 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

Open public recruiting

Date of protocol fixation

2008 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2008 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

All the participants are assessed for their functioning and symptoms, using the Global Assessment of Functioning (GAF), the Positive and Negative Syndrome Scale (PANSS), and the short version of QLS at each measurement point. The participants in the UHR group are also assessed their subthreshold symptoms using the positive scales in the scale of prodromal symptoms (SOPS) at each measurement point. We assess subjective depressive symptom using CES-D, and quality of life using WHO-QOL26 at each measurement point.
For evaluating symptomatic remission, We use a proposal from the Remission in Schizophrenia Working Group that defined symptomatic remission of illness as the correspond 8 PANSS sub-scores (P1, P2, P3, N1, N4, N6, G5, and G9) of mild or less simultaneously on all items, and maintained remission as these scores continued for at least 6 months. For evaluating functional recovery, we assess using the item, TRAINING AND OCCUPATION in the definition sheet adopted by early intervention services in England (http://its-services.org.uk/earlyintervention/resources/) at every year from registration.
If they took any antipsychotics, anxiolytics, and/or antiparkinsonian agents, we calculated the chlorpromazine, diazepam, and biperiden equivalent doses, respectively.


Management information

Registered date

2012 Year 08 Month 09 Day

Last modified on

2023 Year 08 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006204


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name