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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008660
Receipt No. 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 2017/02/12

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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
Middle name
Last name Kiyoto Kasai
Organization The University of Tokyo
Division name Department of Neuropsychiatry, Graduate School of Medicine
Zip code
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
Middle name
Last name Shinsuke Koike
Organization The University of Tokyo
Division name Department of Neuropsychiatry, Graduate School of Medicine
Zip code
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
Institute Department of Neuropsychiatry, Graduate School of Medicine, the University of Tokyo
Institute
Department

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
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 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
2017 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.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


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