Deep Brain Stimulation for Treatment Resistant Depression

NCT ID: NCT05716555

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-14
• Study Completion Date: 2024-03-13

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.

Conditions

Depressive Disorder, Major

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Interventions

Deep brain stimulation

Electrical stimulation of lateral habenula

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Hemmings Wu

Neurosurgeon, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhejiang University School of Medicine Second Affiliated Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hemmings Wu, MD, PhD

Role: CONTACT

hemmings@zju.edu.cn

+86-571-87784716

Facility Contacts

Hemmings Wu, MD, PhD

Role: primary

hemmings@zju.edu.cn

+86-571-87784716

Other Identifiers

IR2021001074

Identifier Type: -

Identifier Source: org_study_id