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Personalized DBS Targeting for Treating Depression

The goal of this clinical trial is to optimize the target brain areas for deep brain stimulation (DBS) for depression based on personalized brain imaging and stereo-electroencephalography（SEEG), to administer long-term DBS treatment in the target brain areas, to assess the effectiveness and safety of DBS for refractory depression and to validate the method of personalized optimization of DBS targets. The main questions it aims to answer are: 1. Where is the optimal DBS target brain region for each patient? 2…

ClinicalTrials.gov IDNCT06784388

PhaseEARLY_PHASE1

Enrollment5

SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine

Age18 Years – 70 Years

SexALL

I'm interested View official listing

Conditions studied

Treatment-resistant Depression (TRD)

About this study

Interventions

Device: Deep Brain Stimulation(DBS) — During the DBS treatment phase, the DBS device will apply electrical stimulation to the patient's target brain regions using a specific strategy, and if the efficacy of this phase is not satisfactory, electrical stimulation will continue to be applied during the efficacy observation phase after DBS shutdown.
Drug: Esketamine — SEEG intraoperative experiment: patients will be implanted with microelectrodes and connected to an electrophysiological recorder under local anesthesia. Intraoperative neurophysiological baseline will be recorded for 5 minutes, and esketamine will be injected intravenously at a dose of 0.5 mg/kg, and neurophysiological recordings will be continued for 15 minutes to observe the neuronal electrophysiological changes in various brain regions and target points.

Primary outcomes

Change in Hamilton Rating Scale for Depression (HAMD) score during the DBS treatment phase relative to preoperative baseline (at baseline and after 442 day)
Changes in HAMD scores during the efficacy observation phase after DBS shutdown (Two months after 442 days)

Eligibility information

Inclusion Criteria: 1. A psychiatrist-confirmed diagnosis of major depressive disorder in accordance with the Diagnostic And Statistical Manual Of Mental Disorders.5th Ed (DSM-V); 2. A psychiatric examination by two trained psychiatrists and a diagnosis consistent with the DSM-V; 3. A history of depression of at least 12 months duration in depressed patients (including MECT) who have failed to respond to a full dose and course of treatment with 2 or more antidepressants of different mechanisms; 4. A 17-item score on the HAMD scale ⩾ 20 at initial screening; 5. A score of ≤ 50 on the Gross Assessment of Functioning (GAF) scale; 6. The patient himself/herself or legal guardian was able to fully understand the therapy and agreed to enroll after signing an informed consent form. Exclusion Criteria: 1. Persons with severe or unstable cardiac, hepatic, renal, endocrine, hematologic, and other medical disorders and co-morbidities with psychotic symptoms, including personality disorders diagnosed by history, questioning, and clinical examination; 2. Persons with psychiatric disorders other than depression (except generalized anxiety); 3. Persons with a history of substance abuse within 12 months; persons with a previous history of epilepsy, and persons with febrile convulsions in childhood; 4. Patients with a history of suicide attempts within the past 6 months or more than 2 suicide attempts within the past 2 years; 5. Women who are breastfeeding, pregnant, and patients who are pregnant or intend to become pregnant during the clinical study; 6. Contraindications to DBS surgery and MRI; 7. Years of education less than or equal to 9 years; 8. Patients who are involuntarily hospitalized.

Study locations

The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang 310000 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-28.