UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007799 |
|---|---|
| Receipt number | R000008983 |
| Scientific Title | Neurophysiological analysis of developmental disorders: an exploratory neuroimaging study using functional near-infrared spectroscopy (fNIRS) |
| Date of disclosure of the study information | 2012/07/01 |
| Last modified on | 2012/04/20 15:07:17 |
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Basic information
Public title
Neurophysiological analysis of developmental disorders: an exploratory neuroimaging study using functional near-infrared spectroscopy (fNIRS)
Acronym
Monitoring of acute effects of Atomoxetine (ATX) on cerebral hemodynamics in ADHD children: an exploratory fNIRS using a Go/NoGo task
Scientific Title
Neurophysiological analysis of developmental disorders: an exploratory neuroimaging study using functional near-infrared spectroscopy (fNIRS)
Scientific Title:Acronym
Monitoring of acute effects of Atomoxetine (ATX) on cerebral hemodynamics in ADHD children: an exploratory fNIRS using a Go/NoGo task
Region
| Japan |
Condition
Condition
ADHD
Classification by specialty
| Pediatrics | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of the study is to confirm the effectiveness of ATX in pediatric ADHD using fNIRS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) fNIRS analysis
Comparison of frontal activation (Oxy-Hb) before and after an acute clinical dose of ATX or placebo (90 min after ATX administration)
Key secondary outcomes
The response of continous administration of ATX on ADHD rating scale and Questionnaire-Children with Difficulties.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Washout for four days - ATX for one day
Interventions/Control_2
Washout for four days - Placebo for one day
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
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All subjects meet the following criteria.
(1) Subjects are under 16 years old and more than 4 years old. Regardless of sex and treatment before this trial.
(2) Subjects are diagnosed with ADHD based on DSM-IV through an interview with more than two pediatric neurologists.
(3) Written informed consent was obtained from the parents of all subjects, and the study was approved by the Ethics Committee of Jichi Medical University Hospital, Japan.
(4) The Wechsler Intelligence Scale of Children-Third Edition (WISC-III) full IQ scores of subjects are over 70
Key exclusion criteria
(1) Subjects who are diagnosed with anxiety disorder
(2) Subjects who are diagnosed with glaucoma
(3) Subjects who are diagnosed with hyperthyroidism
(4) Subjects who have angina, arrhythmia
(5) Subjects who have allergies to ATX
(6) Subjects who are diagnosed with tics or Tourette's syndrome, or have family history of Tourette's syndrome
(7) Subjects who are diagnosed with severe depression
(8) Subjects who are diagnosed with pheochromocytoma
(9) Subjects who current or past use of monoamine oxidase inhibitor (MAOI)
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiju Watanabe |
Organization
Jichi Medical University
Division name
Neurosurgery
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL
0285-58-7373
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiju Watanabe |
Organization
Jichi Medical University
Division name
Neurosurgery
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL
0285-58-7373
Homepage URL
eiju@jichi.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Jichi Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Comprehensive Research on Disability,
Health and Welfare from Health and Labour Sciences Research Grants
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
International University of Health and Welfare Hospital
Name of secondary funder(s)
International University of Health and Welfare
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
とちぎ子ども医療センター（栃木県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 20 | Day |
Last modified on
| 2012 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008983
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