Deep Brain Stimulation for Severe Depression

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

This study is testing if a new brain stimulation treatment can help people with severe depression who haven't found relief from regular medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 47 (estimated)
• Ages: 20 Years to 75 Years
• Sex: All
• Sponsor: University Hospital Freiburg (Academic / other)
• Locations: 2 sites (Grenoble and 1 other locations)
• Trial ID: NCT03653858 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of Deep Brain Stimulation (DBS) in patients suffering from treatment-resistant major depression. It is a multicenter, randomized, sham-controlled, double-blind trial that will compare the antidepressant effects of the Vercise™ GEVIA™ DBS system against a sham procedure. Participants will undergo a neurosurgical procedure to implant electrodes in the medial forebrain bundle, which will then be stimulated with electric pulses. The study focuses on patients who have not responded adequately to traditional antidepressant therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 to 75 with severe major depression who have not responded to multiple antidepressant treatments and therapies.

Not a fit: Patients with mild depression or those who have not undergone adequate trials of existing treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with severe, treatment-resistant depression.

How similar studies have performed: Previous studies have suggested potential benefits of DBS in small patient populations, but this approach is still considered novel for treating depression.

Eligibility criteria

Inclusion Criteria:

1. Major depression (MD), severe, unipolar, or bipolar in an acute depression episode.
2. German mother tongue or fluent.
3. Male or female patients ≥20 and ≤75 years.
4. Hamilton Depression Rating Scale (HDRS-28) score of \>21.
5. Global Assessment of Function (GAF) score of \<45.
6. At least 4 episodes of depression or one chronic episode \>2 years.
7. Failure to respond to

   1. adequate trials of primary antidepressants from at least 3 different classes (\>5 weeks at the maximum recommended or tolerated dose) and
   2. 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
   3. an adequate trial of electroconvulsive therapy (ECT) (\>6 treatments) and an adequate trial of individual psychotherapy (\>20 sessions with an experienced psychotherapist).
8. Able to give written informed consent.
9. Compliance to participate in the study.
10. Drug free or on stable drug regimen at least 6 weeks before study entry.

Exclusion Criteria:

1. Current or past non-affective psychotic disorder.
2. Any current clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome.
3. Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI), any contraindications to perform a planned MRI to visualize the slMFB.
4. 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).
5. Current or unstably remitted substance abuse (aside from nicotine).
6. Pregnancy, women of childbearing age not using effective contraception and breast feeding women.
7. History of severe personality disorder.
8. Acute suicidal ideation.
9. Patients with advanced stage cardiovascular disease.
10. Patients under immunosuppressive or chemo therapy because of malignant disease.
11. Patients who had previous intracranial surgery.
12. Patients who are currently under DBS therapy or have implanted any kind of stimulator already.
13. Patients with aneurysm clips.
14. Patients with cochlear implants.
15. Patients with planned diathermy.
16. Persons who are in a relationship of dependence/employment with the sponsor or the investigator.
17. 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).

Where this trial is running

Grenoble and 1 other locations

• Université Grenoble Alpes — Grenoble, France (Recruiting)
• University Hospital Freiburg — Freiburg, Baden-Württemberg, Germany (Recruiting)

Study contacts

• Principal investigator: Thomas E Schlaepfer, Prof. Dr. — University Hospital Freiburg
• Study coordinator: Thomas E Schlaepfer, Prof. Dr.

Conditions Treatment-resistant Depression; Deep Brain Stimulation; Treatment-resistant depression; Medial forebrain bundle