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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029014
Receipt No. R000033174
Scientific Title Analysis of WISC-IV Cognitive Profile in children with Developmental disability and evaluation of the relationships between WISC-IV Cognitive Profile and effects of pharmacotherapy
Date of disclosure of the study information 2017/11/01
Last modified on 2019/09/07

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Basic information
Public title Analysis of WISC-IV Cognitive Profile in children with Developmental disability and evaluation of the relationships between WISC-IV Cognitive Profile and effects of pharmacotherapy
Acronym Analysis of WISC-IV Cognitive Profile in children with Developmental disability
Scientific Title Analysis of WISC-IV Cognitive Profile in children with Developmental disability and evaluation of the relationships between WISC-IV Cognitive Profile and effects of pharmacotherapy
Scientific Title:Acronym Analysis of WISC-IV Cognitive Profile in children with Developmental disability
Region
Japan

Condition
Condition Developmental disability
Classification by specialty
Pediatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate association between WISC-IV Cognitive Profile and clinical perspective in children with Developmental disability in our institute and to examine relationship the variation of WISC-IV Cognitive Profile and clinical course by therapeutic interventions and pharmacotherapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The Wechsler Intelligence Scale for Children-IV (WISC-IV): Full Scale IQ Verbal. Comprehension Index(Similarities, Vocabulary, and Comprehension). Perceptual Reasoning Index (Block Design, Picture Concepts, and Matrix Reasoning). Working Memory Index (Digit Span and Letter-Number Sequencing). Processing Speed Index (Coding and Symbol Search). Medication information (drug information, dose of medication, dosing period, initial date for medication), Clinical symptom resulted from characteristics of developmental disability.
Key secondary outcomes patient characteristics:Date of birth, sex, past history, birth weight

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
6 years-old <=
Age-upper limit
17 years-old >
Gender Male and Female
Key inclusion criteria 1:All participants has been examined the Wechsler Intelligence Scale for Children-IV (WISC-IV)at the outpatients of Fukuchiyama city hospital from April 2012 to March 2017.
2:All participants who aged 6-16 years old at the age of the enforcement of WISC-IV.
3:All participants who have >70 of Full Scale IQ from the results of WISC-IV.
4:All participants who have been diagnosed as either ADHD or ASD or LD. The overlap of these diagnoses is permitted.
5:2 and 3 are to exclude the influence on immaturity of the development and cognitive characteristic by intellectual disability. The value to divide whether it is intellectual disability is IQ70.
Key exclusion criteria N/A
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hitomi
Middle name
Last name Iwahashi
Organization Fukuchiyama City Hospital
Division name Department of Psychiatry
Zip code 620-8505
Address 231 Atsunaka-cho, Fukuchiyama-City, Kyoto
TEL 0773222101
Email kuwahara@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Hitomi
Middle name
Last name Iwahashi
Organization Fukuchiyama City Hospital
Division name Department of Psychiatry
Zip code 620-8505
Address 231 Atsunaka-cho, Fukuchiyama-City, Kyoto
TEL 0773222101
Homepage URL
Email kuwahara@koto.kpu-m.ac.jp

Sponsor
Institute Fukuchiyama city Hospital
Institute
Department

Funding Source
Organization Fukuchiyama city Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kyoto Prefectural University of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fukuchiyama City Hospital
Address 231 Atsunaka-machi Fukuchiyama-shi Kyoto-fu
Tel 0773222101
Email kuwahara@koto.kpu-m.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 市立福知山市民病院

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information All participants has been examined The Wechsler Intelligence Scale for Children-IV (WISC-IV)at the outpatients of Fukuchiyama city hospital from April 2012 to March 2017.

Management information
Registered date
2017 Year 09 Month 05 Day
Last modified on
2019 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033174

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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