Bipolar Depression
Conditions
Interventions
Control group:Sham stimulation
Sponsors
Beijing Anding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Outpatients or inpatients aged 18-65 years (inclusive), regardless of gender; 2. Meet the diagnostic criteria for "Bipolar Disorder, Current Episode Depressed" according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), without psychotic symptoms; 3. Hamilton Depression Rating Scale for Depression-17 item (HAMD-17) is =17, and Young Mania Rating Scale (YMRS) is =7 before enrollment; 4. Discontinuation of mood stabilizers, antipsychotics, and antidepressants for 5 half-lives before enrollment; 5. No systematic physical therapy such as electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), or tACS within one month prior to enrollment; 6. Have understood all study contents and signed the informed consent form; 7. In addition to the above criteria, subjects who undergo imaging data collection must also meet the following criteria: right-handed; no electronic or metal implants in the body, including pacemakers, coronary stents, defibrillators, or neurostimulation devices incompatible with fMRI.
Exclusion criteria
Exclusion criteria: 1. Meeting the DSM-V criteria for other major psychiatric disorders, such as schizophrenia, schizoaffective disorder, depressive disorder, obsessive-compulsive disorder, etc.; 2. Individuals with an immediate risk of harming themselves or others, specifically those who answer "yes" to items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) during screening or baseline assessment; 3. Currently suffering from severe or unstable physical illnesses; 4. Having comorbid organic brain diseases, such as epilepsy, hydrocephalus, brain injury, ischemic stroke, cerebral hemorrhage, brain tumors, etc.; 5. Individuals with compromised skin integrity at the electrode placement sites, or those allergic to electrode gel or adhesives; 6. Those with implanted electronic stimulators; 7. Participation in any other clinical trial within one month prior to enrollment; 8. Pregnant or lactating women, or individuals unable to use appropriate contraceptive measures during the trial; 9. Any situation deemed inappropriate for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scalefor Depression-17item(HAMD-17);Hamilton Anxiety Scale(HAMA);Young Mania Rating Scale(YRMS);Brief Psychiatric Rating Scale(BPRS);Columbia-Suicide Severity Rating Scale(C-SSRS);the Quick Inventory of Depressive Symptomatology-Self Report(QIDS-SR16); The 7-item Generalized Anxiety Disorder Scale(GAD-7);Pittsburgh sleep quality index(PSQI);Sheehan Disability Scale(SDS);Short Form of Quality of Life Enjoymentand Satisfaction Questionnaire(Q-LES-Q-SF);Cognitive function tests;Electroencephalogram(EEG);functional Magnetic Resonance Imaging (fMRI); | — |
Countries
China
Contacts
Public ContactXu Jinjie
Beijing Anding Hospital, Capital Medical University
Outcome results
None listed