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NCT06542900Not yet recruiting

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

Effectiveness and Safety of Deep Brain Stimulation(DBS) in Treatment-Resistant Depression(TRD)

Source: ClinicalTrials.gov · Last updated 7 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
29 Jan 2024
Start date
10 Aug 2024
Primary completion date
31 Dec 2028
Lead sponsor
Xuanwu Hospital, Beijing
Diseases
Depression
NCT number
NCT06542900

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 10 Aug 2024 to the primary completion date, 31 Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • 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.

Other

  • 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;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Xuanwu Hospital, Capital Medical University
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.