Treatment-Resistant Bipolar Disorder
Conditions
Interventions
The experimental group (NCG-TMS group):Employ the cardiac-brain coupling positioning (NCG-TMS) technology
Control group (fcMRI group):Using the resting-state functional magnetic resonance imaging (fcMRI) navigation technology
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. This episode conforms to the DSM-5 diagnosis of bipolar disorder (Type II) depressive episode. 2. No sustained symptom relief was achieved with at least two different treatment regimens, each using the recommended treatment dosage for at least 8 weeks. These include: Monotherapy: At least two monotherapies, including quetiapine, rulaxitinone, lamotrigine, or olanzapine/fluoxetine combinations. Combination therapy: At least one monotherapy combined with another type of medication, such as lamotrigine, valproic acid sodium, or lithium salts. 3. HAMD >= 20, HAMA >= 14. 4. Age 18-60 years old, right-handed. 5. Signed a written informed consent form, voluntarily participated in the study and accepted the assessment.
Exclusion criteria
Exclusion criteria: 1. Subjects with metallic objects in their bodies or those with other contraindications for MRI scans; 2. Pregnant or lactating women, and women of childbearing age with positive urine HCG test results during the screening period; 3. Those with a strong tendency towards suicide, those who have committed suicide, or those with other mental disorders, including: schizophrenia, mental retardation, substance dependence, etc.; 4. Patients with epilepsy or those with a family history of epilepsy; 5. Patients with severe or unstable physical diseases, such as severe headache, head injury, other nerve damage, high blood pressure and unstable blood pressure, etc.; 6. Researchers consider that there are other situations that make them unsuitable to participate in this clinical trial, such as being unable to complete the tests or being unable to express their feelings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The reduction rate of HAMD-24; | — |
Secondary
| Measure | Time frame |
|---|---|
| HAMA (Hamilton Anxiety Scale) and BSI (Beck Suicide Ideation Scale): Neuro-psychological indicators; | — |
Countries
China
Contacts
Public ContactManli Huang
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed