search
Back to results

Deep Brain Stimulation for Treatment Resistant Depression

Primary Purpose

Depressive Disorder, Major

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Deep brain stimulation
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring deep brain stimulation, lateral habenula

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-70, regardless of gender; Diagnostic And Statistical Manual Of Mental Disorders 5th Ed (DSM-V), for Psychiatrists' Examination of Severe Depressive Disorders; Same diagnostic conclusions based on DSM-V made by two independent psychiatrists; 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) ; HAMD-17 scores ⩾ 20 at screening; Functional General Assessment Table (GAF) rating ≤50; Able to comply with the operational and administrative requirements of participation in the study, and able to give written informed consent. Exclusion Criteria: Patients with severe or unstable mental, liver, kidney, endocrine, hematological diseases, or those with psychotic co-morbidities, including personality disorders; History of substance abuse in the past 12 months; history of epilepsy, or febrile seizure in childhood; Patients who have attempted suicide within the past 6 months, or have had a secondary suicide attempt within the past 2 years; Women who are breastfeeding, pregnant, or intend to be pregnant during the clinical study; Any surgical contraindications to undergoing deep brain stimulation (DBS); Patients who cannot give full informed consent.

Sites / Locations

  • Zhejiang University School of Medicine Second Affiliated HospitalRecruiting

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale
Change in Hamilton Depression Rating Scale score from baseline to 52 weeks after surgery

Secondary Outcome Measures

Full Information

First Posted
December 19, 2022
Last Updated
February 6, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
search

1. Study Identification

Unique Protocol Identification Number
NCT05716555
Brief Title
Deep Brain Stimulation for Treatment Resistant Depression
Official Title
Safety and Efficacy of Deep Brain Stimulation for Treatment Resistant Depression
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2021 (Actual)
Primary Completion Date
March 13, 2023 (Anticipated)
Study Completion Date
March 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
deep brain stimulation, lateral habenula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Deep brain stimulation
Intervention Description
Electrical stimulation of lateral habenula
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale
Description
Change in Hamilton Depression Rating Scale score from baseline to 52 weeks after surgery
Time Frame
52 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-70, regardless of gender; Diagnostic And Statistical Manual Of Mental Disorders 5th Ed (DSM-V), for Psychiatrists' Examination of Severe Depressive Disorders; Same diagnostic conclusions based on DSM-V made by two independent psychiatrists; 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) ; HAMD-17 scores ⩾ 20 at screening; Functional General Assessment Table (GAF) rating ≤50; Able to comply with the operational and administrative requirements of participation in the study, and able to give written informed consent. Exclusion Criteria: Patients with severe or unstable mental, liver, kidney, endocrine, hematological diseases, or those with psychotic co-morbidities, including personality disorders; History of substance abuse in the past 12 months; history of epilepsy, or febrile seizure in childhood; Patients who have attempted suicide within the past 6 months, or have had a secondary suicide attempt within the past 2 years; Women who are breastfeeding, pregnant, or intend to be pregnant during the clinical study; Any surgical contraindications to undergoing deep brain stimulation (DBS); Patients who cannot give full informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hemmings Wu, MD, PhD
Phone
+86-571-87784716
Email
hemmings@zju.edu.cn
Facility Information:
Facility Name
Zhejiang University School of Medicine Second Affiliated Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hemmings Wu, MD, PhD
Phone
+86-571-87784716
Email
hemmings@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Deep Brain Stimulation for Treatment Resistant Depression

We'll reach out to this number within 24 hrs