Bilateral stimulation for treatment-resistant depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama at Birmingham - Dept. of Psychiatry
  Birmingham, Alabama, United States Recruiting
• USC University Hospital
  Los Angeles, California, United States Recruiting
• UCLA Department of Psychiatry
  Los Angeles, California, United States Recruiting
• University of California at Davis
  Sacramento, California, United States Recruiting
• USF Health
  Tampa, Florida, United States Recruiting
• Emory University Hospital
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Brian Kopell, MD — Mount Sinai Hospital
• Study coordinator: Natalie Danovsky
• Email: natalie.richardson@abbott.com
• Phone: +16517563842

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• EEG-Guided TMS for Adults With Depression

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• Ketamine plus behavioral activation therapy for treatment-resistant depression

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• Ketamine-assisted psychotherapy for treatment-resistant depression in adults

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• Mindfulness‑augmented brain stimulation for treatment‑resistant depression

  This trial will test whether combining fast brain stimulation (iTBS) with a digital mindfulness program helps people with treatment‑resistant depression reduce symptoms and improve thinking.

  Recruiting Phase 2 University of California, San Diego · San Diego, California · NCT07512284

• ipRGCs as biomarkers to predict TMS response in major depressive disorder

  This study tests whether retinal cells called ipRGCs can predict who will respond to TMS in treatment-resistant depression.

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• Rapid, robot-guided TMS with NRX-101 for treatment-resistant depression

  This trial tests whether a single-day, robot-guided brain stimulation plus NRX-101 can help adults with treatment-resistant depression compare to sham stimulation and placebo.

  Recruiting at 3 sites Phase 2/3 NeuroRx, Inc. · Sarasota, Florida and 2 other locations · NCT07227103

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.