UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057930 |
|---|---|
| Receipt number | R000066227 |
| Scientific Title | Observational Study on the Efficacy and Safety of Daridorexant for Insomnia Patients (Single-center) |
| Date of disclosure of the study information | 2025/05/23 |
| Last modified on | 2026/01/05 12:05:36 |
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Basic information
Public title
Observational Study on the Efficacy and Safety of Daridorexant for Insomnia Patients (Single-center)
Acronym
Observational Study on Daridorexant (Single-center)
Scientific Title
Observational Study on the Efficacy and Safety of Daridorexant for Insomnia Patients (Single-center)
Scientific Title:Acronym
Observational Study on Daridorexant (Single-center)
Region
| Japan |
Condition
Condition
Insomnia
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect improving insomnia symptoms in a real-world after starting daridorexant treatment, targeting insomnia patients and using the total score of the Athens Insomnia Scale (AIS) as an indicator.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the total score of AIS from the start of daridorexant administration to the fourth week of administration.
Key secondary outcomes
- Change in QIDS-J and PDQ-D-5 scores from the start of daridorexant administration to the fourth week of administration in insomnia patients with comorbid depression.
- Number and frequency of adverse events
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who voluntarily consented to participate in this study.
2) Patients who are 18 years of age or older at the time of consent for this study.
3) Patients diagnosed with insomnia at the research institution and who received their first administration of daridorexant 50 mg between December 2024 and May 2025.
4) Patients for whom the following data are available:
- Records confirming the diagnosis of insomnia.
- Records of the AIS at the start of daridorexant administration and at the fourth week after initiation (21 to 35 days after administration).
5) Patients with a total AIS score of 6 or higher at the start of daridorexant administration.
Key exclusion criteria
1) Patients who fall under contraindications for, or who are using daridorexant off-label.
2) Patients who are administered daridorexant in a manner inconsistent with described in the package insert.
3) Patients who used other insomnia treatment drugs (medications indicated for insomnia) within 28 days before starting daridorexant administration. This includes patients whose prescription from the referring medical institution contains other medications indicated for the treatment of insomnia within 28 days before starting daridorexant administration.
4) Patients with a history of suicidal ideation, suicide attempts, self-harm, or drug overdose.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tetsushi |
| Middle name | |
| Last name | Naomasa |
Organization
Naomasa Clinic
Division name
N/A
Zip code
904-0031
Address
12-18, Uechi, Okinawa City, Okinawa, 904-0031, Japan
TEL
098-989-9229
naomasaclinic1997@gmail.com
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Kubo |
Organization
EPS Corporation
Division name
Clinical Research Center Real World Evidence Business Headquarters
Zip code
162-0814
Address
6-29, Shinogawamachi, Shinjuku-ku, Tokyo, 162-0814, Japan
TEL
03-5803-5045
Homepage URL
prj-dari-cr@eps.co.jp
Sponsor or person
Institute
Naomasa Clinic
Institute
Department
Personal name
Funding Source
Organization
Shionogi & 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 Institutional Review Board
Address
5-20-9-401, Mita, Minato-ku, Tokyo, 108-0073, 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
医療法人三樹会なおまさクリニック（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
31
Results
At week 4, the total score of AIS decreased by 8.6 points from baseline. Scores for all eight AIS items decreased, and the total AIS score was 5 or less in 19 cases. No discontinuations of the study drug due to AE were observed. Participants with comorbid depression, the AIS total score showed a significant reduction by week 4 compared to baseline. The total scores of QIDS-J and PDQ-D-5 also decreased(p<0.01).
Results date posted
| 2026 | Year | 01 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 12 | Month | 23 | Day |
Baseline Characteristics
This study included insomnia participants aged 18 years or older who were treatment-naive, received daridorexant for the first time, had records of the Athens Insomnia Scale (AIS) at both the start of daridorexant administration (baseline) and at week 4, and had a baseline AIS total score of 6 or higher. Participants who had used other insomnia medications (drugs approved for insomnia) within 28 days prior to starting daridorexant, those with contraindications to daridorexant, or those with a history of suicidal ideation, self-injury, or drug overdose were excluded. For participants with comorbid depression, the severity of depression and cognitive function were assessed using records of the Quick Inventory of Depressive Symptomatology (QIDS J) and the short version of the Perceived Deficits Questionnaire for Depression (PDQD5), which are routinely performed in daily clinical practice at our hospital.
Participant flow
Prior to participation in this study, informed consent was obtained from each participant based on an explanatory document approved by the Ethics Review Committee
(Institutional Review Board of the Nonprofit Organization MINS).
Existing information from
consenting participants (such as medical records from routine clinical care) was pseudonymized, and electronic case report forms were created using an Electronic Data Capture (EDC) system.
Authentication and access to the EDC
were managed through ID and
password, and secure communication was ensured by employing encrypted data transmission.
Adverse events
1
Outcome measures
The primary endpoint of this study was the change in the total Athens Insomnia Scale (AIS) score from baseline (at the start of daridorexant administration) to week 4 of treatment. Secondary endpoints included the change in total scores of the depression assessment scales QIDS-J and PDQ-D-5 from baseline to weeks 2, 4, and 8 among insomnia participants with comorbid depression, as well as the incidence of adverse events during the daridorexant treatment period.
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 18 | Day |
Date trial data considered complete
| 2025 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 08 | Month | 31 | Day |
Other
Other related information
Safety
Management information
Registered date
| 2025 | Year | 05 | Month | 21 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066227
