UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025183 |
|---|---|
| Receipt number | 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 | 2025/03/18 01:04:40 |
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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
| 20 | 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
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
itasyun@sj8.so-net.ne.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
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
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
https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85152363434&origin=inward
Publication of results
Published
Result
URL related to results and publications
https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85152363434&origin=inward
Number of participants that the trial has enrolled
55
Results
Ohnishi T et al. Disrupted structural connectivity and less efficient network system in patients with the treatment-naive adult attention-deficit/hyperactivity disorder. Frontiers in psychiatry 2023. Itagaki S et al. Reduced dopamine transporter availability in drug-naive adult attention-deficit/hyperactivity disorder. Psychiatry Clin Neurosci Rep. 2024. Sato A et al. Duration Mismatch Negativity in Adults With Autism Spectrum Disorder Versus Healthy Controls. Neuropsychiatric Disease and Treatment 2025
Results date posted
| 2024 | Year | 09 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 16 | Day |
Baseline Characteristics
Enrollment period: cases were collected from October 2016 to December 2021 (5 years and 3 months).Finally, N=55 [20 ADHD, 15 ASD, 20 HC] cases were accumulated.
Participant flow
Enrollment period: cases were collected from October 2016 to December 2021 (5 years and 3 months).Finally, N=55 [20 ADHD, 15 ASD, 20 HC] cases were accumulated.
Adverse events
None.
Outcome measures
1) Density of dopamine transporter (DAT) in basal ganglia using in vivo SPECT method
2) Mismatch negative potential (MMN) using ERP method
3) Topology of brain network using DT-MRI
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 07 | Day |
Last modified on
| 2025 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028969
