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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Sham-stimulation
DeviceSham-stimulation
Active-stimulation
DeviceActive DBS
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Sham-stimulation groupSham comparator 1 intervention
Group B: Active-stimulation groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in MADRS total score
The MADRS absolute change is measured as score change from baseline to the endpoint evaluation period. The Montgomery Asberg Depression Rating Scale (MADRS) consists of 10 items, and each item is rated on a 7-point Likert scale. The sum of the item scores produces a MADRS total score that ranges from 0 to 60, with higher scores reflecting greater depression severity.
Time frame
12 months2
CGI-I response rate
The CGI-I response is defined as a rating of "very much improved" or "much improved." The Clinical Global Impression of Severity and Improvement (CGI-I) is a clinician-rated tool used to measure the global impression of a treatment response in a patient's by comparing their baseline condition (i.e., before DBS system implant) with their current state.
Time frame
12 monthsSecondary outcomes
1
Percent time in MADRS response
The Montgomery Asberg Depression Rating Scale (MADRS) consists of 10 items, and each item is rated on a 7-point Likert scale. The sum of the item scores produces a MADRS total score that ranges from 0 to 60, with higher scores reflecting greater depression severity.
Time frame
12 Months2
Percent time in MADRS partial response
The Montgomery Asberg Depression Rating Scale (MADRS) consists of 10 items, and each item is rated on a 7-point Likert scale. The sum of the item scores produces a MADRS total score that ranges from 0 to 60, with higher scores reflecting greater depression severity.
Time frame
12 Months3
Percent time in CGI-I partial response
The Clinical Global Impression of Severity and Improvement (CGI-I) is a clinician-rated tool used to measure the global impression of a treatment response in a patient's by comparing their baseline condition (i.e., before DBS system implant) with their current state.
Time frame
12 Months4
MADRS Response Rate
The Montgomery Asberg Depression Rating Scale (MADRS) consists of 10 items, and each item is rated on a 7-point Likert scale. The sum of the item scores produces a MADRS total score that ranges from 0 to 60, with higher scores reflecting greater depression severity.
Time frame
12 MonthsSponsors and contacts
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Source ClinicalTrials.gov