Tests deep brain stimulation for severe depression that has not responded to treatment
Tests implanted brain stimulation in adults with treatment-resistant depression.
Plain-language title generated from the registry record
Registry title: Efficacy of Deep Brain Stimulation(DBS) for Treatment-Resistant Depression(TRD)
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06542900, who can take part
Where in China
- Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xuanwu Hospital, Beijing
- Trial code
- NCT06542900
- Record updated
- 7 August 2024
- Original description
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.Read full original descriptionShow less
Effectiveness and Safety of Deep Brain Stimulation(DBS) in Treatment-Resistant Depression(TRD)
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.
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: 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); have been involved in other clinical studies within three months before enrollment in this study; presence of other psychotic disorders; with a history of traumatic brain injury (TBI); unstable neurological or coagulation disorders; any conditions considered by the study group; presents a suicide risk (defined as a HAMD-17 score of ≥3 on suicide-related items); experience difficulty in effectively communicating with investigators; with intracranial or cardiovascular stents; substance abuse within the past six months; women who are pregnant, lactating, or of childbearing potential who refuse the use of reliable contraception during the study.