Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)
ConditionTreatment Resistant Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorAbbott Medical Devices
About this trial
The goal of this clinical trial is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using Deep Brain Stimulation (DBS) as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) in adults.
Eligibility criteria
Qualifiers
The patient must be diagnosed with non-psychotic unipolar Major Depressive Disorder.
The patient must be in a major depressive episode for ≥12 months or have had at least 3 lifetime depressive episodes.
The patient has tried and failed a minimum of four different types of antidepressant treatments as measured by a tool designed for this purpose.
Depression medication and treatment regimen must be stable for a minimum of 4 weeks before the first baseline visit
Disqualifiers
Pregnant or those who plan to become pregnant during study
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that could limit participation in the study or interfere with adherence to the study protocol.
Current or lifetime history of psychotic features in any Major Depressive Episode.
Has an intracranial Central Nervous System disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication.
Trial design
Treatments tested in this trial
- Sham-stimulation
- Active-stimulation
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov