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Deep Brain Stimulation in Patients With Chronic Treatment Resistant Depression

NCT01973478 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-12-27

No results posted yet for this study

Summary

Major depressive disorders are real public health issues in terms of diagnosis and treatment. Some forms of depression are chronic and resistant to treatment (TRD). In these forms suicide risk is important.

Patients with TRD are potential candidates for neurosurgical interventions to treat depression. However, psychosurgery interventions based upon lesions, showed their limitations related to 1. the large variability in neurosurgical gestures, 2. their side effects, and of course 3. the irreversible damage caused by the surgery.

Thus, deep brain stimulation (DBS) could represent an opportunity for patients suffering from TRD. Our preliminary study based upon the stimulation of the accumbens nucleus showed encouraging results. The investigators have thus planned a randomized controlled trial versus sham stimulation to confirm the therapeutic value of nucleus accumbens DBS.

Conditions

Interventions

DEVICE

DBS

DEVICE

SHAM

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Jean Michel Reymann · CIC INSERM 0203 CHU Rennes

  • Florian Naudet · CIC INSERM 0203 CHU Rennes

  • Bruno Millet · Groupe Hospitalier Pitié-Salpêtrière

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-06-03
Primary Completion
2017-07-03
Completion
2018-11-27

Countries

  • France

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 NCT01973478 on ClinicalTrials.gov