Deep brain stimulation for treatment-resistant depression using advanced imaging techniques

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 study investigates the use of deep brain stimulation (DBS) in the subcallosal cingulate region for patients suffering from treatment-resistant depression. By employing advanced magnetic resonance tractography, the researchers aim to redefine the targeting of DBS to focus on symptomatic networks rather than just structural brain regions. The study will assess the feasibility and safety of this innovative approach, correlating imaging findings with mood score changes over time. Participants will undergo surgery with the Abbott Laboratories Infinity™ implantable DBS system.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Men and women (non-pregnant) between ages 21 and 70;
* DSM-5 diagnosis a current major depressive episode (MDE) for 10 years of less, recurrent or single episode with first episode after adulthood and did not start during childhood or adolescence, secondary to nonpsychotic unipolar major depressive disorder;
* Current index MDE ≥24 months duration and/or recurrent illness with at least a total of 2 lifetime episodes (including current episode \>12 months);
* Treatment resistance (defined by criteria on the Antidepressant Treatment History Form (ATHF)28): Failure to respond to a minimum of four adequate depression treatments from different categories;
* Symptom severity for Screening: Hamilton Depression Rating Scale-17 item (HDRS17) ≥20;
* Symptom severity for Outcome: Montgomery Asberg Rating Scale (MADRS) ≥27 to be met at assessment one week pre-op;
* Normal brain MRI within 3 months of surgery;
* Antidepressant medication regimen has been held stable for ≥ 30 days prior to the study screening MADRS;
* Remain on stable antidepressant medication throughout the study, unless there are safety concerns;
* Montreal Cognitive Assessment (MoCA) \>25;
* Able and willing to give informed consent and agree to attend regular clinic visits for at least 12 months.

Exclusion Criteria:

* DSM-5 Axis I Disorders: any lifetime history of psychotic disorder or bipolar disorder;
* Alcohol or substance use disorder within 6 months, excluding nicotine;
* History of childhood abuse (physical or sexual) 18
* Personality disorders;
* Seeking disability during the trial;
* Current substantial suicidal risk as defined by a plan or clear immediate intent for self-harm, or made any suicide attempt within the last year; (MADRS ≥ 5 including the day of surgery);
* No stable work history;
* Neurological/Medical condition that makes the patient, in the opinion of the surgeon, a poor candidate;

  1. Pregnant or has plans to become pregnant in the next 36 months;
  2. Unable/unable to practice birth control through the period of randomization and withdrawal of therapy;
* Subjects who have a history of a seizure disorder;
* Subjects who will be exposed to diathermy;
* Subjects who have any medical contraindications to undergoing DBS surgery (e.g. infection, coagulopathy, or significant cardiac or other medical risk factors for surgery);
* Subjects with another implanted device such as a cardiac pacemaker, defibrillator or neurostimulator;
* Subjects who have a history of hemorrhagic stroke;
* Subjects who are unable to undergo MRI;
* Subjects who are at increased risk of hemorrhage due to underlying medical conditions or medication.

Where it's running

• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Nader Pouratian, MD, PhD — University of Texas Southwestern Medical Center
• Study coordinator: Nader Pouratian, MD, PhD
• Email: Nader.Pouratian@UTSouthwestern.edu
• Phone: 310/274-2095

Similar studies

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

• EEG-Guided TMS for Adults With Depression

  This study tests whether delivering intermittent theta burst stimulation (iTBS) timed to brain waves using EEG can improve treatment for adults with major depressive disorder who have not responded to usual antidepressants.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07862205

• Ketamine plus behavioral activation therapy for treatment-resistant depression

  This study tests whether adding behavioral activation therapy to ketamine treatment helps adults with treatment-resistant depression feel better than ketamine alone.

  Recruiting Phase 2/3 The Royal's Institute of Mental Health Research · Ottawa, Ontario · NCT07801703

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

  This open-label program tests intravenous ketamine combined with psychotherapy to see if it helps adults with treatment-resistant depression.

  Recruiting Senz · Doorn, Utrecht · NCT07706478

• 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.

  Recruiting Polytechnic Institute of Porto · Porto, Porto District · NCT07474974

• 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.