Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06542094

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

Led by West China Hospital · Updated on 2024-08-07

12

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

Sponsors

W

West China Hospital

Lead Sponsor

B

Beijing Pins Medical Co., Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must sign a research informed consent form before starting any study procedures
  • Age between 16 and 30 years, any gender
  • Diagnosed with Major Depressive Disorder (MDD) based on DSM-V criteria
  • Current depressive episode lasting 2 or more years, or recurrent episodes with at least 4 episodes and current episode at least 1 year
  • Failed at least 3 courses of adequate antidepressant therapy using 2 or more classes of antidepressants and refused, could not tolerate, or found electroconvulsive therapy ineffective
  • Have a HAMD-17 score of 20 or higher or a MADRS score of 25 or higher
  • Able to communicate effectively and provide written informed consent along with legal guardian
Not Eligible

You will not qualify if you...

  • Diagnosis of bipolar disorder, schizoaffective disorder, schizophrenia, or other psychotic disorders
  • Severe personality disorders
  • Severe physical diseases or organic brain diseases
  • Alcohol or substance abuse or dependence diagnosed within 1 year prior to screening
  • Surgical contraindications such as significant medical conditions or inability to stop anticoagulation medications
  • Structural brain abnormalities seen on MRI within 1 year prior to screening
  • MRI contraindications excluding DBS implantation or device
  • Pregnant or breastfeeding
  • Enrolled in another unrelated study
  • Any condition that may endanger safety or prevent successful participation, including family, medical, psychological, social, or geographic factors

AI-Screening

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Trial Site Locations

Total: 1 location

1

West CHina Hospital,Sichuan University

Chengdu, Sichuan, China, 610041

Actively Recruiting

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Research Team

W

wei wang, M.D.

CONTACT

B

Botao Xiong, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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