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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035417
Receipt No. 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 2018/12/31

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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
Middle name
Last name Atsunori SUGIMOTO
Organization Niigata University
Division name Department of Community Psychiatric Medicine, Graduate School of Medical and Dental Sciences
Zip code
Address 757, Asahimachi-dori-ichibancho, Chuo-ku, Niigata City, Niigata Pref.
TEL +81-25-227-2213
Email hatsudai@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsunori SUGIMOTO
Organization Niigata University
Division name Department of Community Psychiatric Medicine, Graduate School of Medical and Dental Sciences
Zip code
Address 757, Asahimachi-dori-ichibancho, Chuo-ku, Niigata City, Niigata Pref.
TEL +81-25-227-2213
Homepage URL
Email hatsudai@med.niigata-u.ac.jp

Sponsor
Institute Department of Community Psychiatric Medicine, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/27474159
Number of participants that the trial has enrolled
Results
The results suggested non-linear pharmacokinetics between the concentration and dose of atomoxetine.
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 Completed
Date of protocol fixation
2012 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 05 Day
Last follow-up date
2017 Year 01 Month 23 Day
Date of closure to data entry
2017 Year 01 Month 23 Day
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
2018 Year 12 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040178

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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