Efficacy Study of Deep Brain Stimulation in Patients With Treatment Resistant Major Depression (NCT03653858) | Clinical Trial Compass
CompletedNot Applicable
Efficacy Study of Deep Brain Stimulation in Patients With Treatment Resistant Major Depression
France, Germany46 participantsStarted 2018-09-03
Plain-language 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.
Who can participate
Age range
20 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Montgomery-Asberg Depression Rating Scale (MADRS) total score
Timeframe: 16 weeks after surgery
2
Time to Montgomery-Asberg Depression Rating Scale (MADRS) augmentation of >5 points or clinical worsening in two consecutive visits after DBS termination
Timeframe: Up to 3 months
3
Assessment of (Serious) Adverse Events related to Investigational Medical Device and / or surgical procedures
Timeframe: From IMD implantation until the end of study; assessed up to 77 weeks
. 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.