Treatment-resistant depression
Conditions
Interventions
Group 1:True dorventral prefrontal stimulation (dlPFC)
Group 2:True orbital frontal lobe stimulation (OFC)
Sponsors
Shanghai Mental Health Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meet the Diagnostic criteria for major depressive episode of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) of the American Psychiatric Association; 2. The following definitions of refractory depression were met: two antidepressants were used in sufficient amounts and courses respectively, both of which suggested poor efficacy; 3. Hamilton Depression Scale (HAMD-17)>=17; 4. Aged 18-65 years (when obtaining informed consent), right-handed, gender unlimited; 5. Medication use (i.e., antidepressants, mood stabilizers, atypical antipsychotics, etc.) remained unchanged at least 2 weeks before entering the study, and the treatment regimen remained stable until 20 treatments (4 weeks) were completed after entering the study; 6. Obtain written informed consent of the subject (or guardian).
Exclusion criteria
Exclusion criteria: 1. After the MINI-International Neuropsychiatric Interview (M.I.N.I.), other axis I mental disorders other than depression were excluded; 2. Patients with acute or chronic renal failure; Cirrhosis or active liver disease; 3. Abnormal laboratory tests are judged to be clinically significant, and the researchers believe that they affect the efficacy of the test or the safety of the patients; 4. Severe or unstable physical illness, including: neurological diseases (delirium, dementia, stroke, epilepsy, migraine, high cranial pressure, craniocerebral surgery, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension (including untreated or uncontrolled hypertension), apnea syndrome, malignancies, immunocompromised patients and patients with blood glucose higher than 12mmol/L; 5. Binge drinking within 30 days before the start of the trial or alcohol or drug dependence within 6 months before the trial; 6. Pregnant and lactating patients. Male and female patients who are not taking effective contraceptive measures or plan to become pregnant within 3 months after the start of the trial; 7. Family history of epilepsy (within three generations); 8. Skin and skull conditions: abnormal electrode placement, such as open wounds; 9. Patients who have recently taken benzodiazepines and antiepileptic mood stabilizers (with 5 half-lives as the calculation standard); 10. Received any neuroregulatory therapy, including electroconvulsive ((M)ECT, transcranial magnetic stimulation (r)TMS, and any type of transcranial electrical stimulation (tES) therapy within the last three months; 11. Those who are claustrophobic and unable to receive fMRI examination (patients who only participate in FMRI scan); 12. The investigator determined that there were other conditions unsuitable for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 17 Hamilton Depression Scale Reduction Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Montgomery Depression Scale Reduction Rate; | — |
Countries
China
Contacts
Public ContactHong Wu
Outcome results
None listed