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

NCT06542094 · tracked via the Priya Life Science China tracker

Sponsor

West China Hospital

Phase

Not applicable

Started

2024-08-03

Last updated

2024-08-07

Condition(s) studied

Major Depressive DisorderTreatment Resistant Depression

Investigational drug(s) / intervention(s)

Deep Brain stimulation

Deep Brain stimulation: All subjects will receive bilateral surgical implantation of DBS system.

Study summary

Major depressive disorder (MDD) is a complex and severe mental illness, characterized by multiple symptoms, and is a leading cause of non-fatal health loss. Despite this, approximately 30% of patients do not respond to standard pharmacological or psychological treatments. Currently, we lack objective brain-based biomarkers to differentiate between natural mood fluctuations and situations requiring intervention. To address this issue, we employed a novel electrophysiology recording device and applied deep brain stimulation (DBS) to 12 MDD patients. Our study aims to use long-term invasive neural signal collection and machine learning techniques to reveal the complex relationship between these signals and depressive symptoms. By applying advanced machine learning algorithms, our goal is to establish highly accurate prediction models to identify biomarkers associated with the occurrence and progression of depression. The research will focus on the spatiotemporal features of neural signals and build personalized depression decoding models based on individual differences through the integration and analysis of large-scale data. By delving into the information contained in neural signals, we hope to contribute to the development of personalized treatment approaches for depression.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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).

Primary outcome measure(s)

Identifying an electrophysiological biomarker of MDD — 30 days
Percentage of patients in which an electrophysiological biomarker of OCD can be identified before initial DBS

Trial sites (1)

Facility	City	Region	Status
West CHina Hospital，Sichuan University	Chengdu	Sichuan	Recruiting

More West China Hospital trials in China

Prognosis and Antiplatelet Strategies for Patients With PCI and High Bleeding Risk:A Study Protocol Recruiting

Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery Recruiting

Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinomas Active, not recruiting

Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma Recruiting

Zusanli (ST36) Electroacupuncture Treatment for Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer Recruiting

Other trials for the same condition

Chinese Longitudinal and Systematic Study of Bioplar Disorder Recruiting

NMDA Modulation in Major Depressive Disorder Recruiting

Accelerated Intermittent Theta-Burst Stimulation Ameliorate Major Depressive Disorder by Regulating CAMKII Pathway Recruiting

Home-Based Wearable rTMS Therapy for Moderate to Severe Depression Starting soon

To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Food Effects of LY03021 in Healthy Chinese Subjects Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06542094 on ClinicalTrials.gov ↗ ← All trials in China