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Adjunctive electroacupuncture and rTMS for patients with treatment-refractory depression: a magnetic resonance imaging study

Phase 1
Conditions
Treatment-refractory depression
Registration Number
ITMCTR2100004669
Lead Sponsor
The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Patients group: 1. Be able to communicate and provide written consent; 2. Diagnosis of major depression identified by treating psychiatrists and confirmed via a checklist of Diagnostic and Statistical Manual of Mental Disorders-4th edition (DSM-IV) criteria; TRD defined as an insufficient therapeutic response to >=2 adequate antidepressants treatment trials during the current episode; 3. Male and female patients aged 18–65 years; 4. A total score of >= 17 on the 17-item Hamilton Rating Scale for Depression (HAMD-17) at screening; 5. Participants must have junior middle school and above years of schooling; 6. Han Chinese patients, right handedness. Healthy control group 1. The subjects or their relatives of the third generation of two lineages did not meet any diagnostic criteria of mental illness in DSM-IV, and were not related to the patients group; The other criteria were 4-6.

Exclusion Criteria

Patients group: (1) Other major psychiatric disorders that meet the DSM-IV diagnostic criteria include organic mental disorders, alcohol dependence, drug dependence/abuse, schizophrenia, etc; (2) Currently, there are serious and unstable somatic diseases such as diabetes, thyroid disease, hypertension, heart disease and narrow-angle glaucoma, etc; Wechsler intelligence test (WAIS-RC) full scale IQ (FIQ) total scores <= 80; (3) A history of neurological diseases such as epilepsy and dementia; (4) Subjects with metal in the body, such as pacemaker or brain electrode; (5) Previous history of anesthetics allergy; (6) Women who are at the stage of pre-pregnancy, pregnancy or lataction; (7) Contraindications to MRI or intolerant of MRI scanning environment, such as claustrophobia. Healthy control group: the same as the patient group. The age, gender and years of education were matched with the patients group.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
safety;tolerability;Efficacy;
Secondary Outcome Measures
NameTimeMethod
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