UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014120 |
|---|---|
| Receipt number | R000016407 |
| Scientific Title | Prospective observational study for psychiatric symptoms of pediatric Basedow's disease |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2021/07/08 14:04:22 |
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Basic information
Public title
Prospective observational study for psychiatric symptoms of pediatric Basedow's disease
Acronym
Prospective observational study for psychiatric symptoms of pediatric Basedow's disease
Scientific Title
Prospective observational study for psychiatric symptoms of pediatric Basedow's disease
Scientific Title:Acronym
Prospective observational study for psychiatric symptoms of pediatric Basedow's disease
Region
| Japan |
Condition
Condition
Basedow's disease
Classification by specialty
| Endocrinology and Metabolism | Pediatrics | Psychiatry |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe clinical characteristics, severity, and improvement course of psychiatric symptoms in Basedow's disease
Basic objectives2
Others
Basic objectives -Others
To study the needs and methods of psychiatric therapy for cases that show psychiatric symptoms
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Description by a child psychiatrist and psychological examination about the course of behavior and emotional and social problems in clinical and borderline cases as assessed by the child behavior checklist (CBCL) and youth self-report (YSR) at the initial visit
Key secondary outcomes
1) point of improvement of psychiatric symptoms
2) point of improvement of GAF
3) frequency of clinical and borderline cases as assessed by CBCL and YSR
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
| 4 | years-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Likely Basedow's disease according to the diagnostic guideline of thyroid disease
2)Patients were aged 4–16 years at the time of initial visit
3)Untreated Basedow's disease
Key exclusion criteria
1)Past medical history of Basedow's disease or chronic thyroiditis
2)To find a case unsuitable by a doctor
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rie Kuge |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Division of Psychology and Welfare
Zip code
Address
2-8-29 Musashidai Fuchu-shi Tokyo
TEL
042-300-5111
rie_kuge@tmhp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rie Kuge |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Division of Psychology and Welfare
Zip code
Address
2-8-29 Musashidai Fuchu-shi Tokyo
TEL
042-300-5111
Homepage URL
rie_kuge@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
東京都立小児総合医療センター
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | 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
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
| 2014 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
clinical characteristics, severity, and improvement course of psychiatric symptoms in Basedow's disease
Management information
Registered date
| 2014 | Year | 05 | Month | 30 | Day |
Last modified on
| 2021 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016407
