Efficacy of Deep Brain Stimulation(DBS) for Treatment-Resistant Depression(TRD)

Launched by XUANWU HOSPITAL, BEIJING · Aug 5, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the use of deep brain stimulation (DBS) as a treatment for people with Treatment-Resistant Depression (TRD). This means they have depression that hasn’t improved despite trying at least two different antidepressant medications. The study will focus on specific areas in the brain that are believed to be involved in mood regulation. It aims to see if implanting a device that delivers electrical stimulation to these areas can help improve symptoms of depression in participants.

To participate, individuals must be between 18 and 65 years old, have a diagnosis of major depression, and have not found relief from previous antidepressant treatments. They should also be stable on their current medications for at least four weeks before the study starts. However, people with certain conditions, such as other mental health disorders, recent substance abuse, or a history of brain injuries, would not be eligible. If selected, participants can expect to undergo the DBS procedure and be monitored for its effects on their depression, helping researchers understand if this treatment could be a viable option for others struggling with similar issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. male or female, 18-65 years old;
• • 2. able to provide written informed consent voluntarily;
• • 3. had a diagnosis of major depression disorder (MDD) (recurrent episodes) without psychotic features in compliance with the Diagnostic and Statistical Manual of Mental Disorders -Fourth Edition -Text Revised (DSM-IV-TR) and confirmed by the Mini-International Neuropsychiatric Interview Chinese version 5.0;
• • 4. failure of response to at least two antidepressant medication trials based on the Massachusetts General Hospital antidepressant treatment response questionnaire (MGH-ATRQ);
• • 5. ongoing antidepressant(s) at a fixed dose for at least four weeks before baseline assessment;
• • 6. had a score of ≥201 on the Hamilton Depression Scale- item 17 (HAMD-17) at baseline.
• Exclusion Criteria:
• • 1. presence of other psychotic disorders;
• • 2. have a treatment history that includes electroconvulsive therapy (ECT), modified electroconvulsive therapy (MECT), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), DBS, and transcranial magnetic stimulation (TMS);
• • 3. presents a suicide risk (defined as a HAMD-17 score of ≥3 on suicide-related items);
• • 4. experience difficulty in effectively communicating with investigators;
• • 5. with a history of traumatic brain injury (TBI);
• • 6. with intracranial or cardiovascular stents;
• • 7. substance abuse within the past six months;
• • 8. unstable neurological or coagulation disorders;
• • 9. women who are pregnant, lactating, or of childbearing potential who refuse the use of reliable contraception during the study;
• • 10. have been involved in other clinical studies within three months before enrollment in this study;
• • 11. any conditions considered by the study group.