Clinical Application of Personalized DBS Target Optimization for Treating Depression

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Early Phase 1
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?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Junming Zhu, Ph.D.
dr.zhujunming@zju.edu.cn
+86 13968055768
Time Frame
Start Date: 2025-01-05
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 5
Treatments
Experimental: Depression
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov