Treatment-resistant depression
Conditions
Interventions
HL intervention group:iTBS 10 times daily
TT intervention group:iTBS 6 times daily
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. The current episode met the DSM-5 diagnostic criteria for major depression, without psychotic symptoms of the first or recurrent drug-free depressive subjects; 2. After a full course of treatment with two or more antidepressants, the patient had no response, and the level of treatment resistance was moderate to severe as assessed by the Maudsley staging method; 3. 24-item Hamilton depression Scale score >=20; 4. The age ranged from 18 to 45 years, both sexes; 5. Right handed; 6. Written informed consent was obtained and patients volunteered to participate in the study and be evaluated.
Exclusion criteria
Exclusion criteria: Related to the subjects: 1. Subjects with metal objects or other MRI scan contraindications in their bodies; 2. Pregnant, lactating women, and women of childbearing age who have a positive urine HCG test result during the screening period; 3. The researchers believe that there are other circumstances that are not suitable for participating in the clinical trial, such as inability to complete the test or inability to express one's feelings. Related to lesions: 1. Strong suicidal tendencies, suicidal behavior, or comorbidities with other mental disorders, including schizophrenia, mental retardation, material dependence, etc; 2. Patients with epilepsy or a family history of epilepsy; 3. Suffering from serious or unstable physical illnesses, such as severe headaches, head injuries, other nerve injuries, high blood pressure, and unstable blood pressure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale (24-items) Total Score Change; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the rate of Hamilton Anxiety Scale score;Change in the rate of Beck Scale of Suicidal Ideation score;Change in the score of THINC-it;Treatment Emergent Symptom Scale;Change in neuroimaging using functional magnetic resonance;Change of blood factor levels;Change in electroencephalogram; | — |
Countries
China
Contacts
Public ContactManli Huang
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed