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

Treatment-resistant Depression Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment-resistant Depression

• NCT number: NCT03653858
• Study type: Interventional
• Source: University Hospital Freiburg
• Contact: Thomas E Schlaepfer, Prof. Dr.
• Phone: +49761270
• Email: thomas.schlaepfer@uniklinik-freiburg.de
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2018
• Completion date: June 2, 2025