Bipolar Disorder
Conditions
Interventions
Group A:Participants in Treatment Group A will receive one session of sham tTIS combined with active rTMS during Phase I (Week 1), followed by a 1-week washout period, and subsequently one session of
Group B:Participants in Treatment Group B will receive one session of active tTIS combined with active rTMS during Phase I (Week 1), followed by a 1-week
Sponsors
Xiangya Second Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Participants voluntarily agree to participate in this study, sign the informed consent form, and are able to comply with scheduled visits, laboratory assessments, and other study procedures. 2.Male or female participants aged 18–65 years. 3.Participants who meet the diagnostic criteria for Bipolar Disorder Type I or Type II according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with the diagnosis further confirmed using the Mini-Structured Clinical Interview for DSM (Mini-SCID). 4.Participants currently experiencing a moderate-to-severe depressive episode without psychotic features, defined as a Montgomery–Åsberg Depression Rating Scale (MADRS) score >= 20 and a Young Mania Rating Scale (YMRS) score <13. 5.Participants receiving one of the following medication regimens: antipsychotic monotherapy, mood stabilizer monotherapy, or a combination of antipsychotics and mood stabilizers; alternatively, participants for whom one of the above treatment regimens is planned by a qualified physician after enrollment. 6.Female participants of childbearing potential must have a negative pregnancy test throughout the study period.
Exclusion criteria
Exclusion criteria: 1.Presence of other severe medical conditions that may interfere with the clinical trial, including but not limited to disorders of the central nervous system; cardiovascular system (including unstable coronary artery disease, congestive heart failure, pathological tachycardia, or recent myocardial infarction); urinary system (including interstitial cystitis); respiratory system; digestive system; endocrine system (including uncontrolled hyperthyroidism); ophthalmologic disorders (including untreated glaucoma or penetrating ocular injury); hematologic disorders; rheumatologic, immunologic, or metabolic diseases (including severe dehydration or hypovolemia). 2.Contraindications to transcranial temporal interference stimulation (tTIS), transcranial magnetic stimulation (TMS), or magnetic resonance imaging (MRI), including but not limited to a history of stroke, brain tumor, intracranial hemorrhage, implanted wires, electrodes, pacemakers, implants, non-removable ferromagnetic objects in the head, history of epilepsy (except childhood febrile seizures), prior brain surgery, moderate-to-severe head injury, or any penetrating head trauma. 3.Meeting DSM-5 diagnostic criteria for other psychiatric disorders, or presence of active psychotic symptoms. 4.Substance abuse or dependence within the past 3 months. 5.Receipt of or ongoing treatment within the past 3 months with electroconvulsive therapy (ECT/MECT), transcranial magnetic stimulation (TMS), transcranial electrical stimulation (TES), deep brain stimulation (DBS), vagus nerve stimulation (VNS), transcranial ultrasound stimulation (TUS), or systematic psychotherapy targeting bipolar disorder. 6.Significant suicidal attempt or suicidal behavior. 7.Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| resting-state functional MRI;Columbia–Suicide Severity Rating Scale (C-SSRS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Beck Depression Inventory-II (BDI-II);17-item Hamilton Depression Rating Scale (HAM-D17);Young Mania Rating Scale (YMRS);Hamilton Anxiety Rating Scale (HAMA);Montgomery–?sberg Depression Rating Scale (MADRS);THINC-it Cognitive Assessment Battery;Clinical Global Impression–Severity Scale (CGI-S);Clinical Global Impression–Improvement Scale (CGI-I);Pittsburgh Sleep Quality Index (PSQI);Electroencephalography (EEG);Routine blood test;Blood biochemistry; | — |
Countries
China
Contacts
Public ContactHaishan Wu
Xiangya Second Hospital of Central South University
Outcome results
None listed