Deep Brain Stimulation for Treatment Resistant Depression

Zhejiang University

Status: Enrolling

Conditions: Depressive Disorder, Major

Treatments: Device: Deep brain stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05716555

IR2021001074

Details and patient eligibility

About

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

Enrollment: 2 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Quadruple Blind