Bipolar II Disorder (Depressive Episode)
Conditions
Interventions
Combined treatment with acupuncture and transcutaneous auricular vagus nerve stimulation (taVNS)
Sponsors
Tokyo Ariake University of Medical and Health Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the MADRS score at 8 weeks Changes from baseline in gene and molecular expression in blood cells and plasma | — |
Countries
Japan
Contacts
Public ContactYuto Matsuura
Tokyo Ariake University of Medical and Health Sciences Department of Acupuncture and Moxibustion
Outcome results
None listed