Personalized deep brain stimulation for treating depression

Clinical Application of Personalized DBS Target Optimization for Treating Depression

This study is testing a personalized deep brain stimulation treatment for people with depression that doesn't improve with other therapies to see if it can help them feel better.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06784388 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to optimize deep brain stimulation (DBS) for treatment-resistant depression by using personalized brain imaging and stereo-electroencephalography (SEEG). Participants will undergo a series of assessments, including preoperative evaluations, SEEG implantation, and long-term DBS treatment, to determine the most effective stimulation targets and parameters for each individual. The study will also explore neural biomarkers associated with depression symptoms and assess the efficacy of the personalized DBS strategies over time.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with major depressive disorder who have not responded to multiple antidepressant treatments.

Not a fit: Patients with severe medical disorders or those with psychotic symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a tailored and effective treatment option for patients suffering from treatment-resistant depression.

How similar studies have performed: While personalized approaches in DBS for depression are emerging, this specific methodology is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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 this trial is running

Hangzhou, Zhejiang

• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Junming Zhu, Ph.D.

Conditions: Treatment-resistant Depression, Treatment-resistant depression, DBS, stimulation target, stimulation parameters, neural biomarker