Major Depression Disorder
Conditions
Interventions
Group A:Deep brain stimulation implantation. The first month is the start-up period, and the second month is the shutdown period.
Group B:Deep brain stimulation implantation. The first month is the shutdown period, and the second month is the start-up period.
Sponsors
the Second Affiliated Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1)18-70 years old, gender not limited; 2) Conform to the diagnosis Of major depressive disorder by a psychiatrist as stipulated in the Diagnostic And Statistical Manual Of Mental Disorders, 4th Ed (DSM-V) of the United States; 3) Mental examinations were conducted by two trained psychiatrists and diagnoses were made in accordance with DSM-V, with consistent diagnoses. 4) A history of depression lasting at least 24 months, for those with a Hamilton Depression Scale (HDRS-17) score reduction rate of no more than 20% after adequate and full-course treatment with two or more antidepressants (including MECT); 5) The score of the 17 items of the HDRS-17 scale at the initial screening is >= 20; 6) The score of the Global Assessment Function (GAF) is <= 50; 7) The patient or their legal guardian must fully understand the therapy and agree to sign the informed consent form before being enrolled in the group.
Exclusion criteria
Exclusion criteria: 1) Patients with severe or unstable internal diseases such as heart, liver, kidney, endocrine, and hematological disorders, as well as those with comorbidities accompanied by psychotic symptoms, including personality disorders diagnosed through medical history, inquiry, and clinical examination; 2) There is a history of drug abuse within 12 months; Those with a history of epilepsy and those with febrile convulsions in childhood; 3) Patients who have attempted suicide within the past six months or more than twice within the past two years; 4) Women who are breastfeeding or pregnant, as well as patients who are pregnant or planning to become pregnant during clinical research; 5) Patients with contraindications to MRI scans (such as cardiac pacemakers, metals in the body, severe claustrophobia), and abnormal brain MRI; 6) Contraindications for DBS surgery and chronic stimulation.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Montgomery-Asberg Depression Rating Scale;Quick Inventory of Depressive Symptomatology;multi-lingual Hypomania Check List;Hamilton Anxiety Scale;HCL-32;Clinical Global Impression;Global Assessment of Function;36-Item Short Form Health Survey;BIS-11;Frontal Assessment Battery;Pittsburgh sleep quality index; | — |
Primary
| Measure | Time frame |
|---|---|
| Hamilton Rating Scale for Depression; | — |
Countries
China
Contacts
Public ContactLiangwen Zhang
the Second Affiliated Hospital of Shandong First Medical University
Outcome results
None listed