UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049863 |
|---|---|
| Receipt number | R000056749 |
| Scientific Title | Predicting adult ADHD using an artificial intelligence (AI) diagnosed tool |
| Date of disclosure of the study information | 2023/01/03 |
| Last modified on | 2024/12/23 12:13:21 |
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Basic information
Public title
Predicting adult ADHD using an artificial intelligence (AI) diagnosed tool
Acronym
Predicting adult ADHD using an artificial intelligence (AI) diagnosed tool
Scientific Title
Predicting adult ADHD using an artificial intelligence (AI) diagnosed tool
Scientific Title:Acronym
Predicting adult ADHD using an artificial intelligence (AI) diagnosed tool
Region
| Japan |
Condition
Condition
attention deficit hyperactivity disorder, ADHD
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to develop and validate an AI model to determine adult ADHD patients
Basic objectives2
Others
Basic objectives -Others
Development and validation of an AI model
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity, specificity, and accuracy of the following AI prediction model
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subject eligibility is determined based on the following criteria before inclusion in the study:
(1) Confirmed diagnosis of ADHD
-Patients diagnosed with ADHD as per DSM-5
-CAARS (T score: 65 or higher )
-AQ-J Score: < 33
-JART score: 85 or higher
(2) Typical developer
-The subject has no history of psychiatric disorders.
-The subject has no psychiatric illness as confirmed by a structured interview in accordance with DSM-5. In this case, M.I.N.I. is used secondarily.
-CAARS (T score: < 65)
-AQ-J Score: < 33
-JART score: 85 or higher
(1)(2) Common
-In the opinion of the investigator or sub-investigator, the subject is capable of understanding and complying with protocol requirements.
-The subject signs and dates a written, informed consent form prior to the initiation of any study procedures.
-The subject is aged 20 to 50 years, inclusive, at the time of informed consent.
-The subject is native Japanese and can conduct interviews (conversations with healthcare professionals).
Key exclusion criteria
Any subject who meets any of the following criteria will not qualify for entry into the study:
-The subject is, in the opinion of the physician, unable to participate in the study due to deafness, dysarthria, aphasia, etc.
-Cognitive impairment due to a nervous system disorder (Epilepsy, stroke, etc.) or other disorders such as head trauma, or a diagnosis of dementia
-The subject has a diagnosis of ASD.
-The subject has a diagnosis of psychiatric illness, including anxiety, obsessive-compulsive and related disorders, traumatic and stress-related disorders, depression, bipolar disorder, schizophrenia spectrum disorder, or limited learning and intellectual disability.
-Other cases where the investigator or sub-investigator judges it difficult to continue the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Miwa |
| Middle name | |
| Last name | Izutsu |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL
03-3278-2111
miwa.izutsu@takeda.com
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Kamijo |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL
03-3278-2111
Homepage URL
nozomi.kamijo@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited.
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Kitamachi Clinic, Toukeikai Medical Corporation.
Address
1-1-3,KichijojiKitamachi,Musashino-si.Tokyo
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.com
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
| 2023 | Year | 01 | Month | 03 | 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
113
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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Predicting adult ADHD using an artificial intelligence (AI) diagnosed tool
Management information
Registered date
| 2022 | Year | 12 | Month | 22 | Day |
Last modified on
| 2024 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056749
