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

  • End date
    Jun 2, 2023
  • participants needed
  • sponsor
    University Hospital Freiburg
Updated on 14 February 2022


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.


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.

Condition Treatment-resistant Depression
Treatment Vercise GEVIA deep brain stimulation (DBS) system
Clinical Study IdentifierNCT03653858
SponsorUniversity Hospital Freiburg
Last Modified on14 February 2022


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Inclusion Criteria

Major depression (MD), severe, unipolar, or bipolar in an acute depression episode
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Male or female patients 20 and 75 years
Hamilton Depression Rating Scale (HDRS-28) score of >21\
Global Assessment of Function (GAF) score of <45\
At least 4 episodes of depression or one chronic episode >2 years
Failure to respond to
adequate trials of primary antidepressants from at least 3 different classes (>5 weeks at the maximum recommended or tolerated dose) and
adequate trials of augmentation/combination of a primary antidepressant (>3 weeks at the usually recommended or maximum tolerated dose) using at least 2 different augmenting/combination agents (lithium, T3, stimulants, neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant) and
an adequate trial of electroconvulsive therapy (ECT) (>6 treatments) and an adequate trial of individual psychotherapy (>20 sessions with an experienced psychotherapist)
Able to give written informed consent
Compliance to participate in the study
Drug free or on stable drug regimen at least 6 weeks before study entry

Exclusion Criteria

Current or past non-affective psychotic disorder
Any current clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome
Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI), any contraindications to perform a planned MRI to visualize the slMFB
Any surgical contraindications to undergoing DBS like deformed or displaced or not discernable target region, scarring after brain disease (infarction), need for continuous anticoagulation that cannot be bridged in order to obtain normal coagulation, present risks for anesthesia or any brain or scalp injury (even after intracranial surgery)
Current or unstably remitted substance abuse (aside from nicotine)
Pregnancy, women of childbearing age not using effective contraception and breast feeding women
History of severe personality disorder
Acute suicidal ideation
Patients with advanced stage cardiovascular disease
Patients under immunosuppressive or chemo therapy because of malignant disease
Patients who had previous intracranial surgery
Patients who are currently under DBS therapy or have implanted any kind of stimulator already
Patients with aneurysm clips
Patients with cochlear implants
Patients with planned diathermy
Persons who are in a relationship of dependence/employment with the sponsor or the investigator
Simultaneous participation or previous participation within 30 days prior to start of screening in a clinical trial involving investigational medicinal product(s) or investigational medical device(s)
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