UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062536 |
|---|---|
| Receipt number | R000071542 |
| Scientific Title | Observational Study of Zuranolone in Patients with Mild Major Depressive Disorder |
| Date of disclosure of the study information | 2026/08/10 |
| Last modified on | 2026/08/10 11:14:21 |
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Basic information
Public title
Observational Study of Zuranolone in Patients with Mild Major Depressive Disorder
Acronym
ROUTE Study
Scientific Title
Observational Study of Zuranolone in Patients with Mild Major Depressive Disorder
Scientific Title:Acronym
ROUTE Study
Region
| Japan |
Condition
Condition
Mild Depression and Depressive Symptoms
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect information on changes regarding depressive symptoms, work productivity, patient global impression of improvement, the symptom that patients consider most concerning, and safety outcomes following the initiation of zuranolone treatment in routine clinical practice among patients with mild depression and depressive symptoms.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study aims to descriptively analyze depressive symptoms, work productivity, patient global impression of improvement, the symptom that patients consider most concerning, and safety in patients taking zuranolone in routine clinical practice, without setting specific primary endpoints. Evaluation measures, centered on the QIDS-J, will be collected.
-The symptom that patients consider most concerning selected from the QIDS-J category at Visit1(baseline).
-Percentage of patients whose symptom that patients consider most concerning selected from the QIDS-J category at Visit1, improved by at least 1 point from Visit 1 at each evaluation point.
-Percentage of patients whose symptom that patients consider most concerning selected from the QIDS-J category at Visit1was 0 at each evaluation point.
-QIDS-J total score at Visit 1 and the trend of scores and changes from baseline at each evaluation point.
-Percentage of patients whose total QIDS-J score was 5 or less at each evaluation point
-Score progression for each item in QIDS-J from Visit 1 to each evaluation point.
-Percentage of patients whose score for each item of the QIDS-J improved by 1 point or more from Visit 1 to each evaluation point.
-In subgroups based on concomitant medications(antidepressants, hypnotic medications), the percentage of patients whose symptom that patients consider most concerning selected from the QIDS-J category at Visit1 improved by 1 point or more from Visit 1 at each evaluation point.
-In subgroups categorized by concomitant medications(antidepressants, hypnotic medications), the changes in the QIDS-J total score(Visit1) and the score at each evaluation point.
-Using WPAI (Work Productivity and Activity Impairment), Labor productivity at each evaluation point compared to Visit1.
-Using PGI-I(Patient Global Impression of Improvement), Patient impression of improvement at each evaluation point compared to Visit1.
-Adverse Events for Safety Assessment.
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
| 64 | years-old | > |
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 written voluntary consent to participate in this study.
2) Male or female patients aged 18 to under 65 at the time of consent acquisition.
3) Patients diagnosed with depression or a depressive symptoms at the study siteat the time of consent acquisition.
4) Patients who are newly starting zuranolone medication, as determined by the principal investigator (or co-investigator) to be appropriate.
5) Patients with a QIDS-J (Quick Inventory of Depressive Symptomatology, Japanese version) total score of 6 to 10 at the first day taking zuranolone.
6) Outpatients.
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.
2) Patients who, on the first day taking Zuranolone, are unable to select one category from the nine categories of the QIDS-J that they perceive as their "most concerning symptom at present."
3) Patients who have been previously administered zuranolone .
4) Patients who have been administered antidepressant treatments within four weeks prior to starting zuranolone.
5) Patients with a history of suicidal ideation, suicide attempts, self-injury, or drug overdose.
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
コスモス通り心身医療クリニック（福島県）
医療法人ＭＧＲ ひいらぎこころクリニック小倉院 （福岡県）
医療法人ＭＧＲ ひいらぎこころクリニック折尾院 （福岡県）
医療法人社団蒼仁会 西岐阜ほんだクリニック（岐阜県）
医療法人社団円遊会門前仲町メンタルクリニック（東京都）
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
Preinitiation
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 | 14 | Day |
Last follow-up date
| 2027 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Multicenter (5 sites), non-interventional,prospective single-arm observational study
Participant recruitment method: Patients visited the study sites after the start of the study who fulfill the inclusion and exclusion criteria
Items: QIDS-J, WPAI, PGI-I, and 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=R000071542
