Deep Brain Stimulation for Treatment Resistant Depression

Depressive Disorder, Major Clinical Trial

Official title:

Safety and Efficacy of Deep Brain Stimulation for Treatment Resistant Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05716555
• Other study ID #: IR2021001074
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2021
• Est. completion date: March 13, 2024

Study information

• Verified date: February 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Hemmings Wu, MD, PhD
• Phone: +86-571-87784716
• Email: hemmings[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: March 13, 2024
• Est. primary completion date: March 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant

Intervention

Device:
• Deep brain stimulation
Electrical stimulation of lateral habenula

Locations

Country	Name	City	State
China	Zhejiang University School of Medicine Second Affiliated Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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