Personalized DBS Targeting for Treating Depression

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for individuals suffering from treatment-resistant depression (TRD), which means they haven’t found relief from other depression treatments. The study aims to personalize deep brain stimulation (DBS) therapy by using advanced brain imaging techniques to identify the best areas in the brain to target for each patient. Researchers will assess how effective and safe this personalized approach is in alleviating depression symptoms and improving overall well-being.

To be eligible for the trial, participants must be diagnosed with major depressive disorder and have struggled with their symptoms for at least a year, despite trying multiple medications. Potential participants should also have a specific level of depression severity as measured by a standardized scale. If someone is interested and meets these criteria, they can expect thorough evaluations from trained doctors, and if they join, they may benefit from a tailored treatment plan aimed at improving their quality of life. It’s important to know that certain medical and psychological conditions may exclude individuals from participating, so a careful screening process will be conducted.

Gender

ALL

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.