Bipolar II disorder
Conditions
Interventions
Precision Positioning Group:Based on individualized brain maps, select precise target points for TMS stimulation
Traditional positioning group:Perform TMS stimulation based on the 10-20 system
Sponsors
Shandong mental health center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for DSM-5 bipolar II disorder and is currently in a major depressive episode; 2. The total score of the 17-item Hamilton Depression Rating Scale (HAMD-17) is >= 17 points, the total score of the Young Mania Rating Scale (YMRS) is <= 7 points, and the total score of the Hamilton Anxiety Scale (HAMA) is < 18 points. 3. Has no psychotic symptoms (such as auditory hallucinations, visual hallucinations, etc.) in the past and currently, and has not been diagnosed with severe mental disorders such as schizophrenia, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder, or panic attacks; 4. Has no contraindications related to magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS); 5. If mood stabilizers (such as lithium salts, valproic acid salts, lamotrigine, etc.) are used, no more than 2 types are allowed. And before screening, the types and doses of the drugs have been basically stable for at least 4 weeks (allowing for minor adjustments due to side effects); 6. Before enrollment, all antidepressants have been discontinued for at least 4 weeks (or more than 5 half-lives).
Exclusion criteria
Exclusion criteria: 1.Other mental disorders; 2.Bipolar I disorder, schizophrenia spectrum disorder, autism spectrum disorder (moderate to severe), major depressive episode with psychotic features, obsessive-compulsive disorder, post-traumatic stress disorder, panic disorder, eating disorder, substance use disorder (within the past 6 months). 3.Major physical and neurological diseases:; 4.Suffering from any unstable or inadequately controlled major physical disease (such as severe heart, liver, or kidney dysfunction, uncontrolled endocrine diseases, autoimmune diseases, hypertension, diabetes, etc.); history of epilepsy; history of intracranial tumors, aneurysms, major brain trauma or surgery; and any contraindications for magnetic resonance imaging (MRI) or repetitive transcranial magnetic stimulation (rTMS) treatment (such as cardiac pacemakers, intracranial metal implants, cochlear implants, etc.). 5.Evaluated as "high risk" according to the Columbia Suicide Severity Rating Scale (C-SSRS), or the investigator judges that there is an immediate risk of self-harm or harm to others. 6.Pregnant, lactating, or women who plan to become pregnant during the study. 7.Known to be allergic to any materials or equipment used in the study. 8.Have received repetitive transcranial magnetic stimulation (rTMS) or modified electroconvulsive therapy (MECT) within the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the score of the 17-item Hamilton Depression Rating Scale (HAMD-17); | — |
Secondary
| Measure | Time frame |
|---|---|
| Childhood Depression Inventory (CDI);Hamilton Anxiety Scale (HAMA);Generalized Anxiety Disorder Scale 7 items (GAD-7);TMS-EEG assessment;Yang's Mania Rating Scale (YMRS);fNIRs assessment;Colombian Suicide Severity Rating Scale (C-SSRS);Patient Health Questionnaire Depression Symptom Cluster Scale 9 items (PHQ-9);Neuroimaging assessment;Childhood Depression Rating Scale - Revised Version (CDRS-R); | — |
Countries
China
Contacts
Public ContactLiu Hao
Shandong mental health center
Outcome results
None listed