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

NCT03653858 | Completed FDA Device

• 3 other identifiers: P000767DRKS00014947CIV-17-07-020746
• Study Type: interventional
• Target: 46
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Treatment-resistant Depression

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Montgomery-Asberg Depression Rating Scale (MADRS) total score

  Primary outcome (Efficacy). MADRS is an established instrument to rate symptoms of depression. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts Each of the 10 items yields a score of 0 to 6. These item scores are summed up to yield a total score. The range of the total score is thus 0 to 60; higher total scores indicate more severe depressive symptoms. Usual cutoff points are: 0 to 6 - normal/symptom absent; 7 to 19 - mild depression; 20 to 34 - moderate depression; \>34 - severe depression

  16 weeks after surgery

• Time to Montgomery-Asberg Depression Rating Scale (MADRS) augmentation of >5 points or clinical worsening in two consecutive visits after DBS termination

  Primary outcome in 2nd stage; Description MADRS: see above.

  Up to 3 months

• Assessment of (Serious) Adverse Events related to Investigational Medical Device and / or surgical procedures

  Primary outcome (Safety); (Serious) adverse events seen will be reported using standard descriptive statistical methods.

  From IMD implantation until the end of study; assessed up to 77 weeks

Secondary Outcomes (46)

• Hamilton Depression Rating Scale (HDRS-28) total score

  16 weeks after surgery

• Clinical Global Impression Score (CGI) total score

  16 weeks after surgery

• Global Assessment of Functioning (GAF) total score

  16 weeks after surgery

• Beck Depression Inventory (BDI-II) total score

  16 weeks after surgery

• 36-Item Short Form Health Survey (SF-36) total score

  16 weeks after surgery

Study Arms (2)

Group A: DBS onset in week 1

EXPERIMENTAL

Implantation of Vercise GEVIA deep brain stimulation (DBS) system. DBS onset in week 1. 2ND STAGE: After 6 months DBS ON, patients will be assessed whether they are responders or non-responders. In the subgroup of eligible responders, patients will be randomized to either DBS OFF\* (for max. 3 months) or continued DBS for another 6 months. \*DBS OFF until worsening of clinical depression, event (defined as \> 5 points augmentation in MADRS in two consecutive visits) or for a maximum of 3 months. After DBS OFF, re-onset of DBS will be performed, followed by 6 months continuous DBS. Non-responders will also receive another 6 months DBS therapy in the 2nd stage. At sites other than Freiburg/Bonn, the 2nd stage consists of 6 months DBS therapy only.

Device: Vercise GEVIA deep brain stimulation (DBS) system

Group B: DBS off, followed by DBS onset in week 17

SHAM COMPARATOR

Implantation of Vercise GEVIA deep brain stimulation (DBS) system. 4 months OFF after implantation followed by DBS onset in first week of month 5. 2ND STAGE: See group A.

Device: Vercise GEVIA deep brain stimulation (DBS) system

Interventions

Vercise GEVIA deep brain stimulation (DBS) system DEVICE

DBS to the superolateral branch of the Medial Forebrain Bundle (slMFB)

Group A: DBS onset in week 1; Group B: DBS off, followed by DBS onset in week 17

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major depression (MD), severe, unipolar, or bipolar in an acute depression episode.
• German mother tongue or fluent.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Freiburg: lead
• Boston Scientific Corporation: collaborator

Study Sites (2)

Université Grenoble Alpes

Grenoble, 38043, France

Location

University Hospital Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Deep Brain Stimulation; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative; Drug Therapy

Study Officials

• Juan Carlos Baldermann-Weiß, PD Dr.

  University Hospital Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Interventional Biological Psychiatry

Model Details: multicenter, randomized, sham-controlled, double blind (patient and observer blinded)

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 31, 2018
• Study Start: September 3, 2018
• Primary Completion: January 7, 2026
• Study Completion: January 7, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

FR (1); DE (1)