Deep Brain Stimulation for Treatment Resistant Depression
Safety and Efficacy of Deep Brain Stimulation for Treatment Resistant Depression
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 14, 2021
CompletedFirst Submitted
Initial submission to the registry
December 19, 2022
CompletedFirst Posted
Study publicly available on registry
February 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2024
CompletedFebruary 8, 2023
February 1, 2023
2 years
December 19, 2022
February 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton Depression Rating Scale
Change in Hamilton Depression Rating Scale score from baseline to 52 weeks after surgery
52 weeks after surgery
Interventions
Electrical stimulation of lateral habenula
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhejiang University School of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, 310009, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neurosurgeon, Assistant Professor
Study Record Dates
First Submitted
December 19, 2022
First Posted
February 8, 2023
Study Start
March 14, 2021
Primary Completion
March 13, 2023
Study Completion
March 13, 2024
Last Updated
February 8, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share