UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014120
Receipt No. 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 2017/06/02

* 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 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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


Contact us.