bipolar depression
Conditions
Interventions
Treatment group:Transcranial Focused Ultrasound (tFUS)
Sham stimulation group:Sham stimulation
Sponsors
Hangzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years; 2. Meet the DSM-5 diagnostic criteria for bipolar depression, with the following specific criteria: a) Mood Disorder Questionnaire (MDQ) score >= 7; b) Montgomery-Åsberg Depression Rating Scale (MADRS) score >= 12; c) Young Mania Rating Scale (YMRS) score <= 14; 3. No history of epilepsy or severe neurological disorders; 4. Have not received any other neuromodulation therapy within the past 30 days; 5. Fit for magnetic resonance imaging (MRI) examination (no metallic implants in the body); 6. Patients or their legal guardians have agreed to participate and signed the informed consent form;
Exclusion criteria
Exclusion criteria: 1. Severe systemic diseases (e.g., cardiac, hepatic, or renal insufficiency) that may pose a health or life risk during the study period; 2. Concurrent severe neuropsychiatric disorders (e.g., schizophrenia, etc.) or developmental delay that may hinder cooperation; 3. Contraindications to magnetic resonance imaging (e.g., presence of metallic implants in the body); 4. Pregnant or breastfeeding women; 5. Substance abuse or alcoholism; 6. Definite suicidal tendency or recent suicidal behavior; 7. History of epilepsy or significant abnormal discharges on electroencephalogram (EEG); 8. Recent (within 3 months) history of traumatic brain injury or brain surgery; 9. Inability to complete the entire study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Young Mania Rating Scale score change;Montgomery-?sberg Depression Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mood Disorder Questionnaire score change;Wisconsin Card Sorting Test scores; | — |
Countries
China
Contacts
Public ContactChunxiao Dai
Hangzhou First People's Hospital
Outcome results
None listed