UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061137 |
|---|---|
| Receipt number | R000069958 |
| Scientific Title | Efficacy and Safety of Adjunctive Brexpiprazole in Patients With Major Depressive Disorder with Anxious Distress: An Exploratory, Multicenter Study |
| Date of disclosure of the study information | 2026/04/02 |
| Last modified on | 2026/04/02 14:34:08 |
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Basic information
Public title
Efficacy and Safety of Adjunctive Brexpiprazole in Patients With Major Depressive Disorder with Anxious Distress: An Exploratory, Multicenter Study
Acronym
Efficacy and Safety of Adjunctive Brexpiprazole in Patients With Major Depressive Disorder with Anxious Distress: An Exploratory, Multicenter Study
Scientific Title
Efficacy and Safety of Adjunctive Brexpiprazole in Patients With Major Depressive Disorder with Anxious Distress: An Exploratory, Multicenter Study
Scientific Title:Acronym
Efficacy and Safety of Adjunctive Brexpiprazole in Patients With Major Depressive Disorder with Anxious Distress: An Exploratory, Multicenter Study
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of brexpiprazole augmentation therapy for depressive symptoms in patients with major depressive disorder with anxious distress
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean change in MADRS total score from baseline to week 6 after initiation of brexpiprazole augmentation therapy in patients with major depressive disorder with anxious distress
Key secondary outcomes
The response rate and remission rate on MADRS and improvement rate on CGI-I at Week 6; and changes from baseline to Week 6 in CUDOS-A, CGI-S, and SDS scores.
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. Outpatients aged 18 years or older at the time of obtaining informed consent
2. Patients diagnosed with major depressive disorder according to DSM-5/DSM-5-TR diagnostic criteria, with the specifier "with anxious distress"
3. Patients who have not achieved sufficient effect despite multiple appropriate treatments with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), etc., for the depressive episode at the time of obtaining consent
4. Patients for whom brexpiprazole augmentation therapy with antidepressants is deemed necessary in routine clinical practice, and who have been additionally prescribed brexpiprazole with SSRIs, SNRIs, or mirtazapine
5. Patients who have received sufficient explanation about participation in this study, fully understood it, and provided written consent of their own free will
Key exclusion criteria
1.Patients who have received antipsychotic medication during the depressive episode period at the time of obtaining consent until the day before obtaining informed consent
2. Other patients deemed inappropriate as research subjects by the principal investigator or sub-investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kato |
| Middle name | |
| Last name | Masaki |
Organization
Kansai Medical University Medical Center
Division name
Department of Neuropsychiatry
Zip code
570-8507
Address
10-15 Fumizono-cho, Moriguchi, Osaka
TEL
06-6992-1001
katom@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Kato |
| Middle name | |
| Last name | Masaki |
Organization
Kansai Medical University Medical Center
Division name
Department of Neuropsychiatry
Zip code
570-8507
Address
10-15 Fumizono-cho, Moriguchi, Osaka
TEL
06-6992-1001
Homepage URL
katom@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Medical Center
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
Kansai Medical University Research Ethics Committee
Address
10-15 Fumizono-cho, Moriguchi, Osaka, 570-8507
Tel
06-6992-1001
rinriirb@hirakata.kmu.ac.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 | 04 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the efficacy and safety of brexpiprazole augmentation therapy for depressive symptoms in patients with major depressive disorder with anxious distress
Management information
Registered date
| 2026 | Year | 04 | Month | 02 | Day |
Last modified on
| 2026 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069958
