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

NCT06542900 | Not Yet Recruiting

• 1 other identifier: DBS for TRD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Treatment Resistant Depression

Keywords

TRD, DBS

Outcome Measures

Primary Outcomes (1)

• The change from baseline to 12 months in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.

  MADRS is an established instrument to rate symptoms of depression. The range of the total score is thus 0 to 60; higher total scores indicate more severe depressive symptoms. Usual cutoff points are: 0 to 6: normal/symptom absent; 7 to 19: mild depression; 20 to 34: moderate depression; \>34: severe depression.

  Baseline to 12 months post-surgery

Secondary Outcomes (12)

• Remission, and response rate at week 2, month 3, month 6, and month 12, revealed by Montgomery-Asberg Depression Rating Scale (MADRS)

  Baseline to week 2, month 3, month 6, and month 12

• the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in the Hamilton Anxiety Rating Scale (HAMA) total score.

  Baseline to week 2, month 3, month 6, and month 12

• the changes of Hamilton Depression Rating Scale, 17 item (HAMD-17) scores and its subscales from baseline to 2 weeks, 3 months, 6 months, and 12 months.

  Baseline to week 2, month 3, month 6, and month 12

• the change of Pittsburgh Sleep Quality Index (PSQI) from baseline to Week 2, Month 3, Month 6, and Month 12.

  Baseline to week 2, month 3, month 6, and month 12

• the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in Clinical Global Impression-Severity scale (CGI-S)

  Baseline to week 2, month 3, month 6, and month 12

Study Arms (1)

Patients with Treatment-Resistant Depression (TRD)

EXPERIMENTAL

Patients will undergo bilateral DBS lead implantation.

Device: Deep Brain Stimulation (DBS)

Interventions

Deep Brain Stimulation (DBS) DEVICE

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.

Patients with Treatment-Resistant Depression (TRD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Hongxing Wang, MD & PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huang Wang, MD

CONTACT

+86 10 83198650; wanghuang118@mail.ccmu.edu.cn

Xiaolei Liu, MD & PhD

CONTACT

+86 10 83198650; ring@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: August 7, 2024
• Study Start: August 10, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 7, 2024

Record last verified: 2024-01

Locations

CN (1)