Identifying brain biomarkers for treatment-resistant major depression using deep brain stimulation
Identifying Local Field Potential Biomarkers for Treatment-Resistant Major Depression With Deep Brain Stimulation
This study is testing if deep brain stimulation can help people with severe depression who haven't found relief from regular treatments by looking for brain signals that could predict their mood changes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06542094 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with treatment-resistant major depressive disorder (MDD) who have not responded to standard treatments. It employs deep brain stimulation (DBS) combined with long-term invasive neural signal collection to identify potential biomarkers associated with depressive symptoms. By utilizing advanced machine learning techniques, the research aims to establish predictive models that can differentiate between natural mood fluctuations and clinical episodes requiring intervention. The study will analyze the spatiotemporal features of neural signals to better understand their relationship with depression.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 16 to 30 who have been diagnosed with major depressive disorder and have not responded to multiple treatment options.
Not a fit: Patients who do not meet the age criteria or have not experienced treatment-resistant depression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the identification of objective biomarkers that improve treatment strategies for patients with treatment-resistant depression.
How similar studies have performed: While there have been studies exploring biomarkers in depression, this approach using deep brain stimulation and machine learning is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Chengdu, Sichuan
- West CHina Hospital，Sichuan University — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: wei wang, M.D.
- Email: wcnsww@163.com
- Phone: +86 13808170699
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.