UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063152 |
|---|---|
| Receipt number | R000067515 |
| Scientific Title | Mapping analysis of disease-specific quality of life measurement and preference-based measurement in adult patients with attention deficit hyperactivity disorder |
| Date of disclosure of the study information | 2026/10/04 |
| Last modified on | 2026/10/02 16:22:06 |
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Basic information
Public title
Mapping analysis of disease-specific quality of life measurement and preference-based measurement in adult patients with attention deficit hyperactivity disorder
Acronym
Mapping analysis between quality of life measurements in adults with attention deficit hyperactivity disorder
Scientific Title
Mapping analysis of disease-specific quality of life measurement and preference-based measurement in adult patients with attention deficit hyperactivity disorder
Scientific Title:Acronym
Mapping analysis between quality of life measurements in adults with attention deficit hyperactivity disorder
Region
| Japan |
Condition
Condition
Attention deficit/hyper activity disorder
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Conduct a questionnaire survey focusing on adults with attention deficit hyperactivity disorder (ADHD) and mapping analysis using the Adult ADHD Quality of Life Scale (AAQoL), a disease-specific quality of life (QOL) measure, to preference-based measures including the EuroQol 5 dimensions 5-level (EQ-5D-5L) and Health Utilities Index Mark 3 (HUI3).
Basic objectives2
Others
Basic objectives -Others
Derive conversion formulas to estimate EQ-5D-5L and HUI values from the AAQOL, a disease-specific QOL measure, using preference-based methods.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
conversion formula for mapping AAQoL to EQ-5D-5L and HUI3
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
| 18 | years-old | <= |
Age-upper limit
| 58 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Have a confirmed diagnosis of attention-deficit/hyperactivity disorder (ADHD).
Be currently receiving medication for ADHD.
Be aged 18 years or older and younger than 58 years at the time of participation.
Be residing in Japan.
Provide informed consent and voluntarily agree to participate in this study.
Key exclusion criteria
Individuals who are unable to provide informed consent or participate in the study due to insufficient Japanese language proficiency.
Individuals who are unable to complete the survey by themselves.
Individuals whose sex reported in the survey is inconsistent with the sex recorded in the panel registration data, excluding responses of "Other" or "Prefer not to answer."
Individuals whose age reported in the survey is inconsistent with the age recorded in the panel registration data; discrepancies of less than 2 years will be considered acceptable.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Kondo |
Organization
Otsuka Pharmaceuticals Co., Ltd
Division name
Department of Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Kondo.Tomohiro.a@otsuka.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Kondo |
Organization
Otsuka Pharmaceuticals Co., Ltd
Division name
Department of Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Homepage URL
Kondo.Tomohiro.a@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceuticals Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceuticals Co., Ltd
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
Non-Profit Organization MINS Research Ethics Committee
Address
Room 401, 5-20-9 Mita, Minato-ku, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.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
| 2026 | Year | 10 | Month | 04 | 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
419
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 13 | Day |
Date of closure to data entry
| 2026 | Year | 04 | Month | 13 | Day |
Date trial data considered complete
| 2026 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2026 | Year | 09 | Month | 30 | Day |
Other
Other related information
To develop mapping algorithms for estimating preference-based utility values, namely the EQ-5D-5L and HUI, from the disease-specific quality-of-life measure AAQOL.
Management information
Registered date
| 2026 | Year | 10 | Month | 02 | Day |
Last modified on
| 2026 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067515
