Treatment-Resistant Depressive Disorder
Conditions
Interventions
Intervention Group:Based on multimodal MRI results, brain functional connectivity was assessed in each patient. All patients received one course of low-intensity transcranial focused ultrasound (tFUS)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-65 years (both males and females). (2) Meet DSM-5 diagnostic criteria for Major Depressive Disorder (MDD), with a HAMD-24 score of 9–34. (3) Treatment-resistant depression (TRD): No significant improvement after standardized treatment with >=2 antidepressant medications. (4) Adequate cognitive and language abilities to complete the study requirements (including reading, writing, and comprehension), and right-handedness. (5) Provide written informed consent: Patients and their families must fully understand the study procedures and voluntarily sign the consent form.
Exclusion criteria
Exclusion criteria: (1) History of psychiatric disorders, including manic episodes, schizophrenia, or other psychotic disorders. (2) Family history of mental illness or suicide/self-harm, OR active suicidal ideation/behavior defined as: MADRS Item 10 (Suicidal Thoughts) score =4, OR any suicidal behavior in the past 6 months per Columbia-Suicide Severity Rating Scale (C-SSRS) ("Actual Attempt", "Interrupted Attempt", or "Aborted Attempt"). (3) Current or past medical history of: Neurological disorders (e.g., encephalitis, peripheral neuropathy, myopathy); Endocrine diseases (e.g., hyper/hypothyroidism, diabetes); Cardiovascular diseases (e.g., hypertension, coronary artery disease); Epilepsy or seizure disorders of any etiology. (4) Substance abuse or dependence history. (5) Pregnant or breastfeeding women. (6) History of traumatic brain injury (TBI). (7) Contraindications to: Transcranial ultrasound therapy; MRI scanning (e.g., cardiac pacemakers, deep brain stimulators, vagus nerve stimulators, metal implants). (8) Participation in other clinical trials within 3 months prior to screening. (9) Other conditions deemed ineligible by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMD-24;Montgomery-Asberg Depression Rating Scale (MADRS) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression-Severity (CGI-S); Clinical Global Impression-Improvement (CGI-I) ; | — |
Countries
China
Contacts
Public ContactQiyong Gong
West China Hospital of Sichuan University
Outcome results
None listed