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The impact of different concentrations of sodium valproate serum on the occurrence of MECT in patients with bipolar disorder

The impact of different concentrations of sodium valproate serum on the occurrence of MECT in patients with bipolar disorder

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077600
Enrollment
Unknown
Registered
2023-11-14
Start date
2023-11-15
Completion date
Unknown
Last updated
2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar disorder, currently in a manic episode

Interventions

0ug/ml sodium valproate concentration group:Sodium valproate, non-convulsive electroconvulsive therapy

Sponsors

Beijing Anding Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

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

MeasureTime frame
MECT onset time;seizure threshold;

Secondary

MeasureTime frame
Yang's Mania Rating Scale Deduction Score;Clinical Gross Impression Scoring Decrement;

Countries

China

Contacts

Public ContactHongli Wang

Beijing Anding Hospital, Capital Medical University

wanghong_li00@163.com+86 132 6328 5642

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026