Deep Brain Stimulation for Treatment Resistant Depression

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05716555
Collaborator
(none)
2
1
36
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Deep brain stimulation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Deep Brain Stimulation for Treatment Resistant Depression
Actual Study Start Date :
Mar 14, 2021
Anticipated Primary Completion Date :
Mar 13, 2023
Anticipated Study Completion Date :
Mar 13, 2024

Outcome Measures

Primary Outcome Measures

  1. Hamilton Depression Rating Scale [52 weeks after surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhejiang University School of Medicine Second Affiliated Hospital Hangzhou Zhejiang China 310009

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hemmings Wu, Neurosurgeon, Assistant Professor, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05716555
Other Study ID Numbers:
  • IR2021001074
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hemmings Wu, Neurosurgeon, Assistant Professor, Second Affiliated Hospital, School of Medicine, Zhejiang University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2023