Deep Brain Stimulation for Treatment Resistant Depression

Safety and Efficacy of Deep Brain Stimulation for Treatment Resistant Depression

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05716555

Enrollment

Registered

2023-02-08

Start date

2021-03-14

Completion date

2024-03-13

Last updated

2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major

Keywords

deep brain stimulation, lateral habenula

Brief summary

This study will investigate the safety and efficacy of deep brain stimulation (DBS) in lateral habenula (LH) for patients with treatment-resistant depression.

Interventions

DEVICEDeep brain stimulation

Electrical stimulation of lateral habenula

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Age 18-70, regardless of gender; 2. Diagnostic And Statistical Manual Of Mental Disorders 5th Ed (DSM-V), for Psychiatrists' Examination of Severe Depressive Disorders; 3. Same diagnostic conclusions based on DSM-V made by two independent psychiatrists; 4. A minimum of 24 months of depressive history, over 2 or more adequate antidepressant trials with Hamilton Depression Rating Scale (HAMD) reduction rate ≤20% (including MECT) ; 5. HAMD-17 scores ⩾ 20 at screening; 6. Functional General Assessment Table (GAF) rating ≤50; 7. Able to comply with the operational and administrative requirements of participation in the study, and able to give written informed consent.

Exclusion criteria

1. Patients with severe or unstable mental, liver, kidney, endocrine, hematological diseases, or those with psychotic co-morbidities, including personality disorders; 2. History of substance abuse in the past 12 months; history of epilepsy, or febrile seizure in childhood; 3. Patients who have attempted suicide within the past 6 months, or have had a secondary suicide attempt within the past 2 years; 4. Women who are breastfeeding, pregnant, or intend to be pregnant during the clinical study; 5. Any surgical contraindications to undergoing deep brain stimulation (DBS); 6. Patients who cannot give full informed consent.

Design outcomes

Primary

Measure	Time frame	Description
Hamilton Depression Rating Scale	52 weeks after surgery	Change in Hamilton Depression Rating Scale score from baseline to 52 weeks after surgery

Countries

China

Contacts

Primary ContactHemmings Wu, MD, PhD

hemmings@zju.edu.cn+86-571-87784716

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026