Identifying brain biomarkers for treatment-resistant major depression using deep brain stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• West CHina Hospital，Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: wei wang, M.D.
• Email: wcnsww@163.com
• Phone: +86 13808170699

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mindfulness‑augmented brain stimulation for treatment‑resistant depression

  This trial will test whether combining fast brain stimulation (iTBS) with a digital mindfulness program helps people with treatment‑resistant depression reduce symptoms and improve thinking.

  Recruiting Phase 2 University of California, San Diego · San Diego, California · NCT07512284

• Adding ketamine to ECT for treatment-resistant depression

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• Maintenance treatment using rTMS for depression

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  Recruiting at 3 sites University of California, San Diego · San Diego, California and 2 other locations · NCT06938841

• Using gamma oscillations to predict ketamine therapy outcomes in depression

  This study is testing if brain activity measured during ketamine treatment can help predict how well it will work for people with depression that hasn't responded to other treatments.

  Recruiting at 2 sites Phase 1 Texas A&M University · Houston, Texas and 1 other locations · NCT06480201

• Understanding the impact of mood disorders and treatment responses

  This study is trying to learn more about how people with depression and bipolar disorder respond to treatment by talking to them weekly for up to 12 weeks to improve future care and predict how well medications might work.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06462196

• Individualized physical activity program for treatment-resistant depression

  This study is testing a personalized exercise program to see if it can help adults with treatment-resistant depression feel better when combined with their usual treatment.

  Recruiting Unity Health Toronto · Toronto, Ontario · NCT06404320

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.