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 Verciseâ„¢ GEVIAâ„¢ DBS system compared to sham.
Who can participate
Age range20 Years – 75 Years
SexALL
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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
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).
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