Depressive Disorder
Conditions
Interventions
Placebo-treated group:Identically appearing oral placebo capsules
Unilateral transcranial magnetic stimulation group :TMS intervention targeting the left DLPFC
Bilateral transcranial magnetic stimulation group:Bilateral DLPFC TMS intervention
Natural observation group :None
Sponsors
Tianjin Anding Hospital
Eligibility
Sex/Gender
All
Age
12 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1.Age between 12-18 years old; 2.Diagnosed with depressive disorder and/or bipolar II disorder (current depressive episode) by a psychiatrist according to DSM-5 criteria, with confirmation via the MINI-KID interview; 3.Montgomery-Åsberg Depression Rating Scale (MADRS) score >= 14; 4.Normal liver and kidney function, with no concurrent acute or chronic organic diseases; 5.Voluntary participation with written informed consent provided by both the participant and their legal guardian.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for FMT Group: 1.Use of antibiotics within the past 1 month or presence of active infection; 2.Comorbid organic diseases of the heart, lungs, liver, kidneys, or other major organs; 3.Diagnosis of other psychiatric or neurological disorders (e.g., bipolar disorder, obsessive-compulsive disorder, epilepsy); 4.History of abdominal surgery; 5.Comorbid metabolic, endocrine, or autoimmune disorders; 6.Presence of genetic or inherited diseases; 7.Current participation in other interventional clinical trials; 8.Any other condition deemed unsuitable for participation by the investigator. Exclusion Criteria for TMS Group: 1.Severe neurological disorders (e.g., epilepsy, stroke, encephalitis, traumatic brain injury) or major systemic illnesses (e.g., malignant tumors, acute heart failure, multi-organ failure); 2.Presence of metal implants above the chest, particularly in the brain or heart (e.g., pacemakers, aneurysm clips); 3.Receipt of electroconvulsive therapy (ECT) within the past 6 months; 4.History of substance or alcohol abuse within the past year; 5.Severe communication impairments that hinder understanding, compliance, or cooperation with treatment and assessments; 6.Current participation in other drug-based or physical therapies (e.g., deep brain stimulation [DBS], ECT, rTMS); 7.Any other condition considered inappropriate by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery-?sberg Depression Rating Scale;Hamilton Depression Rating Scale;Hamilton Anxiety Rating Scale;Columbia-Suicide Severity Rating Scale;Patient Health Questionnaire-9;Generalized Anxiety Disorder-7;Beck Scale for Suicide Ideation ;Snaith-Hamilton Pleasure Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut microbiota analysis;Magnetic Resonance Imaging ;Electroencephalography;Eye-tracking; | — |
Countries
China
Contacts
Public ContactZhang Bin
Tianjin Anding Hospital
Outcome results
None listed