NCT06423430 Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)
| NCT ID | NCT06423430 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abbott Medical Devices |
| Condition | Treatment Resistant Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-09-11 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-09-11 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. The patient must be diagnosed with non-psychotic unipolar Major Depressive Disorder. 2. The patient must be in a major depressive episode for ≥12 months or have had at least 3 lifetime depressive episodes. 3. The patient has tried and failed a minimum of four different types of antidepressant treatments as measured by a tool designed for this purpose. 4. Depression medication and treatment regimen must be stable for a minimum of 4 weeks before the first baseline visit Exclusion Criteria: 1. Pregnant or those who plan to become pregnant during study 2. 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. 3. Current or lifetime history of psychotic features in any Major Depressive Episode. 4. Has an intracranial Central Nervous System disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication. 5. Significant acute suicide risk. 6. Diagnosis of Substance Use Disorder or Alcohol Use Disorder without sustained remission (12 months or longer). 7. Current and ongoing use of neurostimulation treatment that may interfere with DBS therapy/system. 8. Treatment with another investigational device or investigational drugs.
Contact & Investigator
Brian Kopell, MD
PRINCIPAL INVESTIGATOR
MOUNT SINAI HOSPITAL
Frequently Asked Questions
Who can join the NCT06423430 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 70 Years, studying Treatment Resistant Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06423430 currently recruiting?
Yes, NCT06423430 is actively recruiting participants. Contact the research team at bradley.white@abbott.com for enrollment information.
Where is the NCT06423430 trial being conducted?
This trial is being conducted at Birmingham, United States, Los Angeles, United States, Los Angeles, United States, Sacramento, United States and 11 additional locations.
Who is sponsoring the NCT06423430 clinical trial?
NCT06423430 is sponsored by Abbott Medical Devices. The principal investigator is Brian Kopell, MD at MOUNT SINAI HOSPITAL. The trial plans to enroll 100 participants.
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