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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025183
Receipt No. R000028969
Scientific Title The development a diagnostic biomarker for adult attention deficit hyperactivity disorder: A multimodal approach
Date of disclosure of the study information 2017/01/05
Last modified on 2019/06/10

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Basic information
Public title The development a diagnostic biomarker for adult attention deficit hyperactivity disorder: A multimodal approach
Acronym A diagnostic biomarker for adult attention deficit hyperactivity disorder
Scientific Title The development a diagnostic biomarker for adult attention deficit hyperactivity disorder: A multimodal approach
Scientific Title:Acronym A diagnostic biomarker for adult attention deficit hyperactivity disorder
Region
Japan

Condition
Condition Attention deficit hyperactive disorder(ADHD)
Classification by specialty
Neurology Psychosomatic Internal Medicine Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish a diagnostic method based on biomarkers for assistance of accurate diagnosis of adult ADHD
Basic objectives2 Others
Basic objectives -Others See above
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1. DAT BP in the striatum (putamen, caudate nucleus, and Nucleus Accumbens,:NAc,) measured by SPECT.
2. MMN measured by ERP
3. Parameters of brain network topology measured by DT-MRI
Key secondary outcomes 1. Clinical evaluation for ADHD and ASD (each test will be done in all subjects including controls)
1) Conners' Adult ADHD Rating Scales (CAARS)
2) The Adult Autism Spectrum Quotient (AQ)
2. Intelligence quotient with Wechsler Adult Intelligence Scale
3. Measurements of blood concentration of monoamine metabolites; HVA, tMHPG, fMHPG, 5-HIAA

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Measurement of DAT binding potential by using SPRCT
Interventions/Control_2 Diffusion tensor imaging with MRI
Interventions/Control_3 ERP
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
18 years-old <=
Age-upper limit
40 years-old >=
Gender Male and Female
Key inclusion criteria 1. Adult ADHD patients; treatment-naive adult patients fulfilling the DSM5 criteria for ADHD.
2. ASD; treatment-naive adult patients fulfilling the DSM5 criteria for ASD.
3. Age and gender matched healthy subjects.
Key exclusion criteria 1) No history of illicit drug use, antidepressants (at least not over the last3 months) or other psychoactive medication/medication affecting DAT (such as buproprion) in either patients or controls.
2) A history indicating excessive nicotine or alcohol intake (>0.5 packs of cigarettes, >4 glasses of an alcoholic substance a day).
3) Exclusion criteria to MRI: presence of a pacemaker, metallic implants in high-risk areas (i.e. vessel clips) and a history of claustrophobia.
4) Subjects during pregnancy and/or lacting.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Hirooki
Middle name
Last name Yabe
Organization Fukushima Medical University
Division name Neuropsychiatry
Zip code 9601295
Address 1 Hikarigaoka, Fukushima city 960-1295, Japan
TEL 024-547-1111
Email hyabe@fmu.ac.jp

Public contact
Name of contact person
1st name Shuntaro
Middle name
Last name Itagaki
Organization Fukushima Medical University
Division name Neuropsychiatry
Zip code 9601295
Address 1 Hikarigaoka, Fukushima city 960-1295, Japan
TEL 024-547-1111
Homepage URL
Email itasyun@sj8.so-net.ne.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Janssen Pharmaceutical K.K.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fukushima Medical University Institutional Review Board
Address Hikarigaoka-1, Fukushima
Tel 0245471825
Email rs@fmu.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
2017 Year 01 Month 05 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
2016 Year 04 Month 13 Day
Date of IRB
2016 Year 03 Month 29 Day
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 07 Day
Last modified on
2019 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028969

Research Plan
Registered date File name
2017/12/08 20170616 01 研究計画書(別紙様式1)(H280607)20151221ヤンセン_V5板垣改変.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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