UMIN-CTR Clinical Trial

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
Email	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
Email	sugimoto-pedpsy@umin.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	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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040178