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RecruitingEarly Phase 1

Personalized DBS Targeting for Treating Depression

NCT06784388 · Second Affiliated Hospital, Zhejiang University, School of Medicine

Recruiting
Status
Accepting participants
Early Phase 1
Phase
5
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

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. What are the optimal DBS parameters for each patient ? 3. What are the neural biomarkers of depression symptoms for each patient? 4. Are the optimized DBS strategies effective in treating refractory depression?

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Hamilton Rating Scale for Depression (HAMD) score during the DBS treatment phase relative to preoperative baseline

    Measured over at baseline and after 442 day

  • Changes in HAMD scores during the efficacy observation phase after DBS shutdown

    Measured over Two months after 442 days

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 70 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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.

Where

1 study site

FacilityCityRegionCountry
The Second Affiliated Hospital of Zhejiang University School of MedicineHangzhouZhejiangChina

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06784388 on ClinicalTrials.gov →

Last updated in the registry 2026-04-27. Registry records change; this page reflects the data build of 2026-08-25.

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Where this trial sits