UMIN-CTR Clinical Trial

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&#8211;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
Email	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
Email	rie_kuge@tmhp.jp

Sponsor
Institute	Tokyo Metropolitan Children's Medical Center
Institute
Department

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
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	No longer recruiting
Date of protocol fixation	2014 Year 04 Month 28 Day
Date of IRB
Anticipated trial start date	2014 Year 06 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	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	2017 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016407

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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