Identifying Local Field Potential Biomarkers for Treatment-Resistant Major Depression With Deep Brain Stimulation

Launched by WEST CHINA HOSPITAL · Aug 3, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new method to help people with treatment-resistant major depressive disorder (MDD). Researchers are trying to find specific brain signals, called biomarkers, that can help identify when someone with depression might need different treatment. The study involves using a device to record brain activity while applying deep brain stimulation (DBS) in 12 patients. By analyzing these brain signals with advanced computer techniques, the team hopes to develop personalized treatment plans that are more effective for individuals with depression.

To be eligible for the trial, participants should be between 16 and 30 years old, diagnosed with MDD for at least two years, and have not responded to at least three different antidepressant treatments. They also need to have a significant level of depression according to specific scoring systems. Participants can expect to undergo long-term monitoring of their brain activity, which may lead to better understanding and treatment options for depression in the future. It's important to note that certain conditions, like bipolar disorder or severe personality disorders, would exclude someone from participating in this study.

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Eligibility criteria

• Inclusion Criteria:
• • 1) Participants in the study should sign a research informed consent form before starting any research-related procedures; 2) Participants must be between the ages of 16 and 30, regardless of gender; 3) Diagnosed with Major Depressive Disorder (MDD) according to the diagnostic criteria in the DSM-V; 4) Participants must have medical records of their current depressive episode that has lasted for ≥2 years, or recurrent episodes, with a minimum of 4 episodes (with the current episode lasting at least 1 year); 5) Have previously failed at least 3 courses of adequate antidepressant therapy, using 2 or more different classes of antidepressants; and have refused, been unable to tolerate, or found electroconvulsive therapy (ECT) to be ineffective; 6) Participants must have a HAMD-17 score of ≥20 or a MADRS score of ≥25; 7) Participants must be able to communicate effectively, and the participant and their legal guardian must sign a written informed consent form.
• Exclusion Criteria:
• • 1) Participants with bipolar disorder, schizoaffective disorder, schizophrenia, or other psychotic disorders; 2) Severe personality disorders; 3) Severe physical diseases or organic brain diseases; 4) Participants with alcohol or substance abuse and dependence diagnosed within 1 year prior to screening according to DSM-IV criteria; 5) Participants with surgical contraindications, such as significant comorbid medical conditions or inability to discontinue anticoagulation medications; 6) Structural imaging abnormalities evident on MRI performed within 1 year prior to screening; 7) MRI contraindications (excluding DBS implantation or the device itself); 8) Pregnant or breastfeeding; 9) Participants who are enrolled in another study unrelated to the current study; 10) Any condition that may currently or potentially endanger the participant's safety or preclude their successful participation in the study (family support, medical, psychological, social, or geographic factors).