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Clinical Trials in China / NCT06542900
Starting soon Not applicable

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

NCT06542900 · tracked via the Priya Life Science China tracker
Sponsor
Xuanwu Hospital, Beijing
Phase
Not applicable
Started
2024-08-10
Last updated
2024-08-07

Condition(s) studied

Treatment Resistant Depression

Investigational drug(s) / intervention(s)

Deep Brain Stimulation (DBS)

Deep Brain Stimulation (DBS): The DBS lead is stereotactically introduced into the target in the brain (SCC, VC/VS, ALIC, ITP, NAc, LHb, MFB, or other unreported nuclei targets) and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region.

Study 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 striatum (VC/VS), Brodmann area 25/subcallosal cingulate (SCC), Anterior Limb of Internal Capsule (ALIC), inferior thalamic peduncle (ITP), nucleus accumbens (NAc), lateral habenula (LHb), medial forebrain bundle (MFB), or other unreported nuclei targets.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Xuanwu Hospital, Capital Medical University Beijing China

More Xuanwu Hospital, Beijing trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06542900 on ClinicalTrials.gov ↗ ← All trials in China