Home › Trials › NCT06423430

Bilateral stimulation for treatment-resistant depression

Treatment ResistAnt Depression Subcallosal CingulatE Network DBS

Not applicable Interventional Abbott Medical Devices · NCT06423430

This study is testing if a new brain stimulation treatment can help adults with severe depression who haven't found relief from other medications.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment100 (estimated)
Ages22 Years to 70 Years
SexAll
SponsorAbbott Medical Devices Industry-sponsored
Locations28 sites (Birmingham, Alabama and 27 other locations)
Trial IDNCT06423430 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter using Deep Brain Stimulation (DBS) as an adjunctive treatment for adults with non-psychotic unipolar Major Depressive Disorder who have not responded to at least four antidepressant treatments. The study is designed as a prospective, multi-centered, double-blind, randomized trial with a delayed-stimulation/sham-stimulation control over a 12-month period. Participants will be randomly assigned to receive either active DBS therapy or sham stimulation, with the aim of assessing improvements in depressive symptoms. After the study period, all participants will have the opportunity to receive active treatment.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with non-psychotic unipolar Major Depressive Disorder who have experienced a major depressive episode for at least 12 months and have failed multiple antidepressant treatments.

Not a fit: Patients with psychotic features in their depressive episodes or those with other significant medical or psychological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from treatment-resistant depression.

How similar studies have performed: Other studies using Deep Brain Stimulation for treatment-resistant depression have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Treatment Resistant DepressionDBSMajor Depressive DisorderBilateral StimulationAntidepressant TreatmentneurostimulationABT-CIP-10494
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.