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The Efficacy and Prediction of Deep Brain Stimulation for Treatment-resistant Depression

NCT04530942 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-03-25

No results posted yet for this study

Summary

Several open-label trials have shown the therapeutic promise of deep brain stimulation (DBS) targeted to striatal and surrounding capsular areas in treatment-resistant depression (TRD). However, the results of placebo-controlled trials have been mixed, with one showing a large difference between active and sham DBS and another finding no difference.

Main aim of this study is establishing whether active DBS results in more treatment responders than sham DBS. Secondary aims are establishing an adverse events profile, establishing effects on quality of life,neuropsychological and neuroimaging measures, and finding predictors of response.

Conditions

Interventions

DEVICE

Deep brain stimulation(Active)

DBS On with the optiomal parameters

DEVICE

Deep brain stimulation(Sham)

DBS On with 0V Amplitude

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Bomin Sun, PhD · Ruijin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-29
Primary Completion
2024-04-30
Completion
2024-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04530942 on ClinicalTrials.gov