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
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
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
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
