Depression
Conditions
Interventions
active stimulation group:Transcranial focused ultrasound active-stimulation
pseudo-stimulation group:Transcranial focused ultrasound pseudo-stimulation group
Sponsors
Affiliated Kangning Hospital of Ningbo University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-60 years old; 2. Depression was independently diagnosed by two psychiatrists according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); 3. Total score of HAMD-24 items >20 points; 4. Right-handed; 5. The patient's physical examination, medical history, vital signs, routine blood, urine and stool, liver and kidney function, electrolyte, electrocardiogram, electroencephalogram and other indicators were normal; 6. After fully understanding the safety of transcranial focused ultrasound, they are willing to actively cooperate with the treatment and have their informed consent signed by them and their family members.
Exclusion criteria
Exclusion criteria: 1. Age 60 years old; 2. Patients with a history of severe physical illness and depression caused by other psychoactive substances or non-dependent substances; 3. Patients with metal or electronic instruments, such as intracranial metal foreign bodies, cochlear implants, cardiac pacemakers, stents and other metal foreign bodies; 4. have the risk of seizures, previous craniocerebral disease, head trauma, alcoholism, EEG abnormalities, MRI evidence of brain structural abnormalities, or a family history of epilepsy; 5. Acute suicide victims; 6. People with psychotic symptoms who need to be combined with antipsychotic drugs; 7. Received ECT within 2 months before enrollment; 8. pregnant, breastfeeding or planning pregnancy during the trial; 9. Refusal to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale (HAMD-24) ;Self-rating Depression Scale (SDS) ;Self-rating Anxiety Scale (SAS);Baker Suicide Ideation Scale Chinese version (BSI-CV) ;Neuropsychological Status Rating Scale (RBANS) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Electromyographic changes;Neuroelectrophysiological indicators;Hamilton Anxiety Scale (HAMA) ; | — |
Countries
China
Contacts
Public ContactLi Xingxing
Affiliated Kangning Hospital of Ningbo University
Outcome results
None listed