Bipolar disorder, currently in a manic episode
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Inpatients, aged 18 to 65 years (including 18 and 65), of any gender; 2) Meeting the diagnostic criteria for bipolar disorder according to the International Classification of Diseases, 10th Revision (ICD-10), currently in the manic phase, with either first onset or recurrence; 3) No treatment with MECT/ECT, TMS, tDCS, or other therapies in the month prior to enrollment; 4) A score of =12 on the Young Mania Rating Scale (YMRS); 5) Written informed consent from the patient themselves and their guardian or legal representative.
Exclusion criteria
Exclusion criteria: 1) Currently suffering from severe physical illnesses, surgeries, or injuries, including coronary heart disease, tumors, etc.; skin integrity at the electrode placement site is compromised, and allergic to electrode gel or adhesive. 2) Currently suffering from organic mental disorders, including severe heart, liver, kidney, eye, nervous system, endocrine system, and blood system diseases, excluding epilepsy, malignant tumors, and cranial trauma patients, etc. 3) Patients with a history of substance abuse or acute poisoning with psychoactive substances in the past 6 months. 4) Significant clinically relevant abnormalities in electrocardiogram examination or routine laboratory results (complete blood count, biochemistry), as it may affect treatment efficacy and safety evaluation. 5) Concurrent use of other mood stabilizers besides sodium valproate or physical treatments other than MECT. 6) Patients who have undergone MECT treatment within 6 months prior to enrollment. 7) Pregnant, lactating women, or those planning pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MECT onset time;seizure threshold; | — |
Secondary
| Measure | Time frame |
|---|---|
| Yang's Mania Rating Scale Deduction Score;Clinical Gross Impression Scoring Decrement; | — |
Countries
China
Contacts
Beijing Anding Hospital, Capital Medical University