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Efficacy Study of Deep Brain Stimulation in Patients With Treatment Resistant Major Depression

NCT03653858 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-04-28

No results posted yet for this study

Summary

The primary objective of this multicenter, randomized, sham-controlled, double blind (patient and observer blinded) clinical trial is to assess the antidepressant effect of Deep Brain Stimulation (DBS) in patients with treatment resistant major depression using the Boston Scientific implantable Vercise™ GEVIA™ DBS system compared to sham.

Conditions

  • Treatment-resistant Depression

Interventions

DEVICE

Vercise GEVIA deep brain stimulation (DBS) system

DBS to the superolateral branch of the Medial Forebrain Bundle (slMFB)

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • University Hospital Freiburg

    lead OTHER

Principal Investigators

  • Juan Carlos Baldermann-Weiß, PD Dr. · University Hospital Freiburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-03
Primary Completion
2026-01-07
Completion
2026-01-07
FDA Device
Yes

Countries

  • France
  • Germany

Study Locations

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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 NCT03653858 on ClinicalTrials.gov