UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026205 |
|---|---|
| Receipt number | R000029602 |
| Scientific Title | A study of psychotic experiences and risk of suicide reattempt in child and adolescent population |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2023/01/02 10:28:27 |
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Basic information
Public title
A study of psychotic experiences and risk of suicide reattempt in child and adolescent population
Acronym
A study of psychotic experiences and suicide in child and adolescent
Scientific Title
A study of psychotic experiences and risk of suicide reattempt in child and adolescent population
Scientific Title:Acronym
A study of psychotic experiences and suicide in child and adolescent
Region
| Japan |
Condition
Condition
10-15 y.o. patients with experience of suicide attempt
Classification by specialty
| Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The previous studies report the association between psychotic experiences and suicidal behaviors among child and adolescent population. however, it is not still clear about risk of suicide re-attempt and psychotic experiences.
Basic objectives2
Others
Basic objectives -Others
The aim of study is to clear the association between psychotic experiences and 6 months outcome of youth with experience of suicide attempt.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
number of suicide attempt among 6 months
Key secondary outcomes
discontinuation of attending at outpatient clinics
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
| 10 | years-old | <= |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients who replied "yes" to self-questionnaire, asking suicidal plan within 2 weeks before first visit.
Key exclusion criteria
1) patients who relied to self-questionnaire inadequately
2) patients with mental retardation
3) patients without psychiatric diagnosis
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Fujita |
Organization
Yokohama City University Hospital
Division name
Child psychiatry
Zip code
234-0006
Address
3-9,Fukuura,Kanazawa-ku, Yokohama-city
TEL
+81457872800
jun1182@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Aoyama |
| Middle name | |
| Last name | Kumi |
Organization
Yokohama City University Center Hospital
Division name
Child psychiatry
Zip code
232-0024
Address
4-57,Bandobashi,Minami-ku, Yokohama-city
TEL
+81452615656
Homepage URL
kuaoyama@yokohama-cu.ac.jp
Sponsor or person
Institute
Ministry of education
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University
Address
3-9,Fukuura,Kanazawa-ku, Yokohama-city
Tel
+81453707627
rinri@yokohama-cu.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
横浜市立大学附属病院、神奈川県立こども医療センター、横浜市立大学附属市民総合医療センター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | 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
39
Results
Thirteen of 39 (33.3%) of the subjects had some psychotic symptoms, 8 (20.5%) experienced auditory hallucinations, and 9 (23.1%) experienced visual hallucinations. Of the 12 subjects who could be followed, 4 (30.7%) remained psychotic until 24 weeks, and an additional 3 (23.1%) had psychotic symptoms that were detrimental to the subject until 24 weeks. Three of the 12 subjects (23.1%) had a history of suicidal reattempts during the follow-up.
Results date posted
| 2023 | Year | 01 | Month | 02 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
It is difficult to reach the planned sample size.
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
Terminated
Date of protocol fixation
| 2016 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
under going/ 43 patients were registered (02/23/2021)
Management information
Registered date
| 2017 | Year | 02 | Month | 18 | Day |
Last modified on
| 2023 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029602
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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