UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058018 |
|---|---|
| Receipt number | R000066316 |
| Scientific Title | An Exploratory Study on the Anti-Stress Effects of Acupuncture Treatment for Bipolar II Disorder |
| Date of disclosure of the study information | 2025/05/29 |
| Last modified on | 2025/05/29 17:41:46 |
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Basic information
Public title
An Exploratory Study on the Anti-Stress Effects of Acupuncture Treatment for Bipolar II Disorder
Acronym
Exploratory Study on Acupuncture for Stress Reduction in Bipolar II Depression
Scientific Title
An Exploratory Study on the Anti-Stress Effects of Acupuncture Treatment for Bipolar II Disorder
Scientific Title:Acronym
Exploratory Study on Acupuncture for Stress Reduction in Bipolar II Depression
Region
| Japan |
Condition
Condition
Bipolar II Disorder (Depressive Episode)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Peripheral blood samples from patients with Bipolar II Disorder (depressive episode) will be used to: (1) explore objective stress indicators (stress markers) based on gene and molecular expression in blood cells and plasma; and (2) evaluate the effects of acupuncture treatment on depressive symptoms and stress markers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline in the MADRS score at 8 weeks
Changes from baseline in gene and molecular expression in blood cells and plasma
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Combined treatment with acupuncture and transcutaneous auricular vagus nerve stimulation (taVNS)
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Aged 18 years or older at the time of obtaining informed consent
(2) Diagnosis of Bipolar II Disorder according to DSM-5
(3) Meets the criteria for a depressive episode at screening
(4) MADRS score of 20 or higher (moderate depression) at screening
Key exclusion criteria
(1) Schizophrenia and related disorders (with psychotic symptoms), epilepsy, or a history thereof
(2) Four or more manic/hypomanic episodes in the past 12 months
(3) Depression secondary to cerebrovascular disease
(4) Severe liver, kidney, or hematological disease
(5) Presence of malignancy requiring active treatment
(6) Pregnant or lactating women, or women who may be pregnant
(7) Individuals with severe suicidal ideation and judged by a physician to be at high risk of suicide
(8) Personality disorders or intellectual disability
(9) Substance dependence or drug abuse
(10) Use of a cardiac pacemaker or implantable cardioverter-defibrillator
(11) Any other individuals deemed unsuitable for participation by the principal or co-investigator(s)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuto |
| Middle name | |
| Last name | Matsuura |
Organization
Tokyo Ariake University of Medical and Health Sciences
Division name
Department of Acupuncture and Moxibustion
Zip code
1350063
Address
2-9-1 Ariake, Koto-ku, Tokyo, Japan
TEL
0367037000
matsuuray@tau.ac.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Matsuura |
Organization
Tokyo Ariake University of Medical and Health Sciences
Division name
Department of Acupuncture and Moxibustion
Zip code
1350063
Address
2-9-1 Ariake, Koto-ku, Tokyo, Japan
TEL
0367037000
Homepage URL
matsuuray@tau.ac.jp
Sponsor or person
Institute
Tokyo Ariake University of Medical and Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Himorogi Psychiatric Institute
Address
2-31-3 Ichigaya-Tamachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5946-8584
nagamatsu.nami@shintokukai.org
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
| 2025 | Year | 05 | Month | 29 | 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
| 2025 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 29 | Day |
Last modified on
| 2025 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066316
