UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035417 |
|---|---|
| Receipt number | R000040178 |
| Scientific Title | The prediction of effects and side effects of ADHD treatment drugs (atomoxetine and methylphenidate). |
| Date of disclosure of the study information | 2018/12/31 |
| Last modified on | 2022/07/09 14:39:19 |
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Basic information
Public title
The prediction of effects and side effects of ADHD treatment drugs (atomoxetine and methylphenidate).
Acronym
The prediction of effects and side effects of ADHD treatment drugs (atomoxetine and methylphenidate).
Scientific Title
The prediction of effects and side effects of ADHD treatment drugs (atomoxetine and methylphenidate).
Scientific Title:Acronym
The prediction of effects and side effects of ADHD treatment drugs (atomoxetine and methylphenidate).
Region
| Japan |
Condition
Condition
Attention deficit / hyperactivity disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study aims to predict effects and side effects before administration of anti-multi-atomic atomoxetine and methylphenidate by Near-Infrared Spectroscopy (NIRS) and / or gene polymorphism.
Methylphenidate (Concerta) and atomoxetine (Strattera) are approved domestically as a treatment drug for Attention Deficit / Hyperactivity Disorder (ADHD), but in both drugs, there are 30 to 40% of ineffective cases.Particularly in atomoxetine, taking into consideration the features such as requiring 4 to 6 weeks until adequate effect appears from the start of administration, its research value is high if its effect / side effect can be predicted before use.Moreover, if it can contribute to the elucidation of the mechanism of medicine from cerebral blood flow measured by gene polymorphism and NIRS, it also has high research value.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prefrontal cortical activity by NIRS measurement and ADHD-RS(children), CAARS(adults) at baseline and 8 weeks after drug administration.
Key secondary outcomes
Polymorphisms of CYP2D6, DAT and NET
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The 8 weeks administration of atimoxetine (start with dose of 0.5-0.8mg/kg, and increase to 1.0-1.2, 1.5-1.8mg/kg every 2 weeks. In the case with adverse effect or sufficient effect, continue the same dose. If the side effect was severe, change the drug to methylphenidate).
Interventions/Control_2
If the effect of atomoxetine is inadequate (ADHD - RS is 20 points or more and ADHD - RS improvement is less than 40%), or if it is forced to change to another drug due to side effects, we have a 2 week wash out period. And then, 8 weeks of methylphenidate administration (starting amount is 18 mg, increase to 36, 54 mg every 2 weeks, if the side effect is present or the effect is sufficient, continue with the same amount. If the side effect is severe, medication is aborted and the study ends).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
ADHD
Key exclusion criteria
other drugs
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsunori |
| Middle name | |
| Last name | SUGIMOTO |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Community Psychiatric Medicine
Zip code
9518510
Address
757, Asahimachi-dori-ichibancho, Chuo-ku, Niigata City, Niigata Pref.
TEL
+81-25-227-2213
sugimoto-pedpsy@umin.ac.jp
Public contact
Name of contact person
| 1st name | Atsunori |
| Middle name | |
| Last name | SUGIMOTO |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Community Psychiatric Medicine
Zip code
9518510
Address
757, Asahimachi-dori-ichibancho, Chuo-ku, Niigata City, Niigata Pref.
TEL
+81-25-227-2213
Homepage URL
sugimoto-pedpsy@umin.ac.jp
Sponsor or person
Institute
Department of Community Psychiatric Medicine, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Community Psychiatric Medicine, Niigata University Graduate School of Medical and Dental Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Genetic Ethics Review Committee of Niigata University School of Medicine
Address
757, Asahimachi-dori-ichibancho, Chuo-ku, Niigata City, Niigata Pref.
Tel
+81-25-227-2625
ethics@adm.niigata-u.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
https://doi.org/10.3389/fnhum.2021.755025
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3389/fnhum.2021.755025
Number of participants that the trial has enrolled
31
Results
See the article.
Results date posted
| 2022 | Year | 07 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
See the article.
Participant flow
See the article.
Adverse events
See the article.
Outcome measures
See the article.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 31 | Day |
Last modified on
| 2022 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040178
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
