UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062537 |
|---|---|
| Receipt number | R000071543 |
| Scientific Title | A Retrospective Observational Study to Evaluate Real-World Use of Zuranolone in Patients with Major Depressive Disorder |
| Date of disclosure of the study information | 2026/08/10 |
| Last modified on | 2026/08/10 11:31:21 |
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Basic information
Public title
A Retrospective Observational Study to Evaluate Real-World Use of Zuranolone in Patients with Major Depressive Disorder
Acronym
ORIENT Study
Scientific Title
A Retrospective Observational Study to Evaluate Real-World Use of Zuranolone in Patients with Major Depressive Disorder
Scientific Title:Acronym
ORIENT Study
Region
| Japan |
Condition
Condition
Depression and Depressive Symptoms
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To descriptively evaluate the course of depressive symptoms following initiation of Zuranolone treatment in routine clinical practice among patients with depression and depressive symptoms, using the total score of the Quick Inventory of Depressive Symptomatology (QIDS-J, Japanese version) as the assessment measure.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline in the QIDS-J total score at 2 weeks after initiation of zuranolone treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be eligible for inclusion in this study:
1) Patients who have provided voluntary consent for participation in the study including the use of their data for research purposes.
2) Male or female patients aged 18 years of older at the time of initiation of zuranolone treatment.
3) Patients who were diagnosed with depression or depressive states at the study site and received their first administration of zuranolone between March 2026 and June 2026.
4) Patients for whom the following data are available.
.Documentation confirming the diagnosis of depression or depressive states
.Documentation confirming the date of initiation of zuranolone treatment.
.A QIDS-J assessment at the time of initiation of zuranolone treatment.
5) Patients with a QIDS-J total score of 6 points or higher at the time of initiation of zuranolone treatment.
Key exclusion criteria
Patients who meet any of the following criteria will be excluded from this study:
1) Patients who are outside the approved indication for zuranolone or have a contraindication to zuranolone.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Soichi |
| Middle name | |
| Last name | Kono |
Organization
Cosmos Street Psychosomatic Clinic
Division name
Psychiatry
Zip code
963-0207
Address
3-69 Narukami, Koriyama City, Fukushima, 963-0207, Japan
TEL
024-962-7202
papilk-no@diary.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Ishikawa |
Organization
APOPLUS STATION CO.LTD.
Division name
Clinical Operation Dept. Clinical Reserch and Development Group
Zip code
103-0027
Address
Front Place Nihonbashi 2-14-1, Nihonbashi Chuo-ku, Tokyo 103-0027, Japan
TEL
03-6386-8804
Homepage URL
Zuz@apoplus.co.jp
Sponsor or person
Institute
Cosmos Street Psychosomatic 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
Yoyogi Mental Clinic Research Ethics Committee
Address
3F, 4-26-11 Sendagaya, Shibuya-ku, Tokyo
Tel
03-6455-4173
cns_jimu@triad-j.co.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
| 2026 | Year | 08 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design:Retrospective single-arm observational study
Subject recruitment method: Patients fulfilled all the inclusion and exclusion criteria
Items: QIDS-J, Adverse events
Management information
Registered date
| 2026 | Year | 08 | Month | 10 | Day |
Last modified on
| 2026 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071543
