Bipolar depression
Conditions
Interventions
active stimulation group:tACS
sham stimualtion group:sham stimulation
Sponsors
Shanghai mental health center
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–60 years, no gender restrictions; 2. Right-handed, with normal hearing, vision, or corrected vision; 3. Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for major depressive episode in bipolar disorder; 4. Hamilton Depression Scale (HAMD-17) score >= 17; 5. Subjects with a high school education or higher to ensure comprehension and completion of necessary study measurements; 6. Medication regimen (including antidepressants, mood stabilizers, atypical antipsychotics, etc.) unchanged for at least 2 weeks prior to study entry, with treatment plan remaining stable until completion of 30 treatment sessions (6 weeks) after study entry; 7. Written informed consent obtained from the subject and legal guardian.
Exclusion criteria
Exclusion criteria: 1. Exclusion of other Axis I mental disorders besides bipolar disorder major depressive episodes, and exclusion of bipolar disorder manic episodes or hypomanic episodes, as determined by the MINI-International Neuropsychiatric Interview (MINI); 2. Patients with acute or chronic renal failure; patients with liver cirrhosis or active liver disease; 3. Abnormal laboratory findings deemed clinically significant by the investigator, potentially affecting study efficacy or subject safety; 4. Severe or unstable physical illnesses, including: neurological disorders (delirium, dementia, stroke, epilepsy, migraine, increased intracranial pressure, cranial surgery, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension (including untreated or uncontrolled hypertension), sleep apnea syndrome, malignancy, immunocompromised subjects, and subjects with blood glucose levels exceeding 12 mmol/L; 5. Individuals who have engaged in heavy drinking within 30 days prior to trial initiation or who have a history of alcohol or drug dependence within 6 months prior to trial entry; 6. Pregnant or lactating women. Male or female subjects not using effective contraception, or those planning to conceive or become pregnant within 3 months after trial initiation; 7. Family history of epilepsy (within two generations on either side); 8. Skin/cranial conditions: Abnormal electrode placement sites, such as open wounds; 9. Recent use of benzodiazepines, antiepileptic drugs, or mood stabilizers (calculated based on 5 drug half-lives); 10. Received any neuromodulation therapy within the past three months, including electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or any form of transcranial electrical stimulation (tES); 11. Presence of Hi-tACS contraindications: intracranial metallic foreign bodies, pacemakers, cochlear implants, or intracranial hypertension; 12. Participation in any clinical trial within 30 days prior to baseline; 13. Patients exhibiting significant negative, impulsive, or disruptive behaviors that preclude examination cooperation; 14. Presence of pronounced psychotic symptoms; 15. Other conditions deemed by the investigator to make participation in this clinical trial inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The reduction rate in HAMD-17 scores at the end of the sixth week of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of change in assessment scores for QIDS-16, HAMA, YMRS, PSQI, BPRS, WCST, Stroop, PDQ-D, and GAF; | — |
Countries
China
Contacts
Public ContactYiming Chen
Shanghai Mental Health Center
Outcome results
None listed