NCT03653858

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

Controlled Randomized Clinical Trial to Assess Efficacy of Deep Brain Stimulation (DBS) of the slMFB in Patients With Treatment Resistant Major Depression

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: University Hospital Freiburg · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The main objective of this clinical trial is to assess the putative antidepressant efficacy of a therapeutic method called Deep Brain Stimulation (DBS) in patients suffering from severe, treatment-resistant depression, i.e. in patients who have not sufficiently improved under established antidepressant therapies (such as psychotherapy, antidepressant drug therapy, and electroconvulsive therapy). DBS, also known as "brain pacemaker" therapy, is a neurosurgical therapeutic method that is widely established for the treatment of other conditions such as Parkinson's disease. However, DBS is not yet approved for the treatment of patients with depression. In order to initiate DBS treatment, a neurosurgical procedure is performed in which electrodes are placed in a brain region termed 'medial forebrain bundle' (MFB). The electrodes are then used to stimulate this region with electric pulses. From previous investigations and studies with small numbers of patients, it is believed that DBS might have a positive effect on depressive symptoms in patients treated with the method.

Conditions

• Treatment-resistant Depression

Interventions

Type	Name	Description
DEVICE	Vercise GEVIA deep brain stimulation (DBS) system	DBS to the superolateral branch of the Medial Forebrain Bundle (slMFB)

Timeline

• Start date: 2018-09-03
• Primary completion: 2025-06-02
• Completion: 2025-06-02
• First posted: 2018-08-31
• Last updated: 2022-11-03

Locations

2 sites across 2 countries: France, Germany