Major Depressive Disorder
Conditions
Interventions
Hippocampus-targeted Low-intensity Group:tFUS is targeted to the left hippocampal head.
Hippocampus-targeted High-intensity Group:tFUS is targeted to the left hippocampal head.
Sham Stimulation Group:tFUS is targeted to the left hippocampal head. The sham stimulation group uses ultrasound transducers visually identical to the real group's devices but contains internal sound-
Sponsors
Beijing Anding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-65 years, any gender, right-handed, with a minimum educational level of junior high school; (2) Meet DSM-5 diagnostic criteria for recurrent MDD as confirmed by the M.I.N.I. 7.0.2, without psychotic features in the current episode; (3) No antidepressant use during the current episode or within the past month; (4) 17< HAMD-17 score <=24, HAMA-14 score <14; (5) No neuromodulation therapies (e.g., TMS, tDCS) within 30 days before enrollment; (6) Provided written informed consent after understanding study procedures.
Exclusion criteria
Exclusion criteria: (1) Current or previous diagnosis of any major psychiatric disorder under DSM-5 criteria (excluding major depressive disorder), such as neurodevelopmental disorders, neurocognitive disorders, schizophrenia or other psychotic disorders, bipolar disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder (PTSD), alcohol or drug dependence/abuse, or personality disorders; (2) Depressive episodes secondary to organic mental disorders caused by systemic diseases (e.g., hypothyroidism) or neurological conditions; (3) Contraindications to tFUS or MRI, including electronic or metal implants in the body or along the intracranial acoustic pathway (e.g., pacemakers, coronary stents, defibrillators, or MRI-incompatible neurostimulation devices); (4) Severe or unstable neurological disorders (e.g., brain tumors, epilepsy, traumatic brain injury), cardiovascular/respiratory/hepatic/renal/endocrine/hematologic diseases, unstable vital signs, or other systemic conditions deemed unsafe by the investigator; (5) Pregnant or lactating individuals, or patients unable to use proper contraceptive measures during the trial; (6) Patients with significant suicidal risk (HAMD-17 Item 3 score =3), marked impulsivity, or non-compliance; (7) History of electroconvulsive therapy (ECT/MECT) within the past 6 months; (8) Participation in other clinical trials within the preceding 3 months; (9) Any condition considered by the investigator to render the subject unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMD score reduction at week 2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Early effectiveness at 1 week;Effectiveness at 4 week;Cognitive Assessment;EEG changes;MRI changes; | — |
Countries
China
Contacts
Public ContactGang Wang
Beijing Anding Hospital, Capital Medical University
Outcome results
None listed