UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001542 |
|---|---|
| Receipt number | R000001866 |
| Scientific Title | An exploratory study for development of hemodynamic indicators for clinical effectiveness of methylphenidate in children with AD/HD |
| Date of disclosure of the study information | 2008/12/02 |
| Last modified on | 2008/12/02 14:42:37 |
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Basic information
Public title
An exploratory study for development of hemodynamic indicators for clinical effectiveness of methylphenidate in children with AD/HD
Acronym
An exploratory study for development of hemodynamic indicators for clinical effectiveness of methylphenidate in children with AD/HD
Scientific Title
An exploratory study for development of hemodynamic indicators for clinical effectiveness of methylphenidate in children with AD/HD
Scientific Title:Acronym
An exploratory study for development of hemodynamic indicators for clinical effectiveness of methylphenidate in children with AD/HD
Region
| Japan |
Condition
Condition
Attention-deficit/hyperactivity disorder
Classification by specialty
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The object of the current study is to find neurophysiological parameters related with clinical effectiveness of methylphenidate in children with AD/HD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relation between hemodynamic changes detected by near-infrared spectroscopy and difference of AD/HD symptoms.
Key secondary outcomes
1) Assessment of behavioral disturbances(CBCL)
2) Assessment of general function(GAF)
3) Assessment of comorbidities(SCAS,CDRS,PARS)
4) Assessment of self-estimate(JSSC)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
8-week methylphenidate administration
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
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. A patient who is more than 6-yaer old and under 12-year old when informed consent was obtained from their parents or guardians.
2. A patient who is diagnosed to have AD/HD by child psychiatrists or child neurologists based on DSM-IV-TR.
3. A patient whose parents or guradians can give written informed consent.
Key exclusion criteria
1. A patient with severe anxiety or agitation.
2. A patient with glaucoma.
3. A patient with thyroidal dysfunction
4. A patient with arrythmia or abnormal blood pressure.
5. A patient with history of allergic reaction or severe side effects with methylphenidate.
6. A patient with severe mood disorder
7. A patient with motor tics, Tourette's syndrome, or family history of Tourette's syndrome.
8. A patient with pheochromocytoma.
9. A patient who receives medication of MAO inhibitor.
10. A patient with epilepsy.
11. A patient with schizophrenia, psychotic disorders, bipolar disorder.
12. A patient with history of drug abuse or alcohol dependence.
13. A patient with significant mental retardation (FIQ<70, WISC-III).
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ozawa |
Organization
Shimada Ryoiku Center
Division name
Department of Pediatrics
Zip code
Address
1-31-1 Nakazawa, Tama City, Tokyo, Japan
TEL
042-374-2071
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ozawa |
Organization
Shimada Ryoiku Center
Division name
Department of Pediatrics
Zip code
Address
1-31-1 Nakazawa, Tama City, Tokyo, Japan
TEL
042-374-2071
Homepage URL
h.ozawa@shimada-ryoiku.or.jp
Sponsor or person
Institute
Shimada Ryoiku 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
1.National Center of Neurology and Psychiatry
2.Rissho University
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 12 | Month | 02 | 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
Date of protocol fixation
| 2008 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 02 | Day |
Last modified on
| 2008 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001866
