NCT06784388RecruitingEarly phase 1
Personalized DBS Targeting for Treating Depression
Clinical Application of Personalized DBS Target Optimization for Treating Depression
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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?
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- First submitted
- 14 Jan 2025
- Start date
- 5 Jan 2025
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Depression
- NCT number
- NCT06784388
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 5
- From 5 Jan 2025 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Persons with a history of substance abuse within 12 months; persons with a previous history of epilepsy, and persons with febrile convulsions in childhood;
- Contraindications to DBS surgery and MRI;
Other illness
- 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;
- Persons with psychiatric disorders other than depression (except generalized anxiety);
- Patients with a history of suicide attempts within the past 6 months or more than 2 suicide attempts within the past 2 years;
Other
- Women who are breastfeeding, pregnant, and patients who are pregnant or intend to become pregnant during the clinical study;
- Years of education less than or equal to 9 years;
- Patients who are involuntarily hospitalized.
Who the study is looking for
- A psychiatrist-confirmed diagnosis of major depressive disorder in accordance with the Diagnostic And Statistical Manual Of Mental Disorders.5th Ed (DSM-V);
- A psychiatric examination by two trained psychiatrists and a diagnosis consistent with the DSM-V;
- 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;
- A 17-item score on the HAMD scale ⩾ 20 at initial screening;
- A score of ≤ 50 on the Gross Assessment of Functioning (GAF) scale;
- The patient himself/herself or legal guardian was able to fully understand the therapy and agreed to enroll after signing an informed consent form.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.