Status:
NOT_YET_RECRUITING
Efficacy of Deep Brain Stimulation(DBS) for Treatment-Resistant Depression(TRD)
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Treatment Resistant Depression
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The primary purpose of this study is to investigate the effect of deep brain stimulation (DBS) implantation in patients with Treatment-resistant Depression (TRD) targeting the ventral capsule/ventral ...
Detailed Description
At least 40-60% of people with major depressive disorders (MDD) continue to have symptoms after treatment. The pharmacology treatment cannot produce sustained antidepressant effects in 50% of patients...
Eligibility Criteria
Inclusion
- male or female, 18-65 years old;
- able to provide written informed consent voluntarily;
- 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;
- failure of response to at least two antidepressant medication trials based on the Massachusetts General Hospital antidepressant treatment response questionnaire (MGH-ATRQ);
- ongoing antidepressant(s) at a fixed dose for at least four weeks before baseline assessment;
- had a score of ≥201 on the Hamilton Depression Scale- item 17 (HAMD-17) at baseline.
Exclusion
- presence of other psychotic disorders;
- 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);
- presents a suicide risk (defined as a HAMD-17 score of ≥3 on suicide-related items);
- experience difficulty in effectively communicating with investigators;
- with a history of traumatic brain injury (TBI);
- with intracranial or cardiovascular stents;
- substance abuse within the past six months;
- unstable neurological or coagulation disorders;
- women who are pregnant, lactating, or of childbearing potential who refuse the use of reliable contraception during the study;
- have been involved in other clinical studies within three months before enrollment in this study;
- any conditions considered by the study group.
Key Trial Info
Start Date :
August 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06542900
Start Date
August 10 2024
End Date
December 31 2029
Last Update
August 7 2024
Active Locations (1)
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1
Xuanwu Hospital, Capital Medical University
Beijing, China, 100053