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 |
* 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
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
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/
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
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
