Open Label Optimization (OLO) Clinical Research Program
Evaluating the SAINT™ neuromodulation system for the Treatment of Major Depressive Disorder
The prospective, multi-site Open Label Optimization (OLO) clinical research program is now enrolling up to 1,000 adults throughout the U.S. experiencing a major depressive episode who have failed to receive satisfactory improvement from a prior antidepressant medication. The OLO clinical research program is designed to further evaluate the effectiveness of the SAINT™ Neuromodulation System for the treatment of adults with major depressive disorder (MDD) in a real-world setting.
ELIGIBILITY
A complete list of eligibility and exclusion criteria will be explained to you by the program doctor.
You must be 18 years or older and have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
You have a confirmed primary clinical diagnosis of MDD. You are able to have a brain MRI scan. You are not pregnant.
To see if you or a loved one qualifies for this groundbreaking SAINT™ neuromodulation system clinical research program, contact the site nearest to you using the map.
THE SAINT™ NEUROMODULATION SYSTEM
The SAINT™ neuromodulation system is a novel treatment for depression. SAINT™ uses non-invasive magnetic stimulation with personalized targeting to specific areas of the brain associated with depression. The treatment is investigational and delivers accelerated, personalized targeted stimulation to regions in the brain to treat MDD.
SAINT™ therapy is delivered on an accelerated timeline—10 sessions a day, composed of 10‑minute treatments with 50‑minute breaks for five consecutive days.
PARTICIPATION DETAILS
DURATION
Each patient will participate in follow-up for 1 year. This will include the treatment and follow-up calls.
COST
There is a cost to participate in the OLO clinical research program.
For more information, please contact the program site. Additional clinical trial information may be found at clinicaltrials.gov.
In completed clinical trials, delivery of SAINT™ therapy for MDD has resulted in a significant reduction in depressive symptoms following the five-day treatment protocol.
Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial
Summary: Depression is the leading cause of disability worldwide, and half of patients with depression have treatment-resistant depression. This clinical study tested the safety and effectiveness of personalized neurostimulation with a novel protocol for Major Depressive Disorder (MDD). The study was designed to address the limitations of the current intermittent theta-burst stimulation (iTBS). Results from the double-blinded randomized controlled trial (RCT) evaluating SAINT demonstrate that this novel approach has the promise to be a reproducible, rapid and effective treatment for severe, intractable depression. Fourteen people received active treatment, and another 15 people received sham (placebo) treatment. The results indicate that 79% of people in the active treatment arm entered remission—compared to people in the sham or control treatment arm, where 13% of the people entered remission from depression.
View Authors Eleanor J. Cole, Ph.D., Angela L. Phillips, Ph.D., Brandon S. Bentzley, M.D., Ph.D., Katy H. Stimpson, B.S., Romina Nejad, M.S., Fahim Barmak, M.D., Clive Veerapal, B.S., Naushaba Khan, B.S., Kirsten Cherian, Ph.D., Emily Felber, M.S., Randi Brown, M.S., Elizabeth Choi, M.S., Sinead King, Ph.D., Heather Pankow, B.S., James H. Bishop, Ph.D., Azeezat Azeez, Ph.D., John Coetzee, Ph.D., Rachel Rapier, B.S., Nicole Odenwald, M.A., David Carreon, M.D., Jessica Hawkins, B.A., Maureen Chang, B.S., Jennifer Keller, Ph.D., Kristin Raj, M.D., Charles DeBattista, M.D., Booil Jo, Ph.D., Flint M. Espil, Ph.D., Alan F. Schatzberg, M.D., Keith D. Sudheimer, Ph.D., Nolan R. Williams, M.D
Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression
Summary: New antidepressant treatments are needed that are effective, rapid-acting, safe and tolerable. The study examined the feasibility, tolerability and preliminary effectiveness of SAINT neuromodulation treatment for treatment-resistant depression. Twenty-two participants with treatment-resistant depression received open-label SAINT treatment. One participant withdrew, leaving a sample size of 21. Nineteen of 21 participants (90.5%) entered remission based on the Montgomery-Åsberg Depression Rating Scale (MADRS). Neuropsychological testing demonstrated no negative cognitive side effects.
View Authors Eleanor J. Cole, Ph.D., Katy H. Stimpson, B.S., Brandon S. Bentzley, M.D., Ph.D., Merve Gulser, B.S., Kirsten Cherian, Ph.D., Claudia Tischler, B.S., Romina Nejad, M.S., Heather Pankow, B.S., Elizabeth Choi, B.S., Haley Aaron, B.S., Flint M. Espil, Ph.D., Jaspreet Pannu, B.S., Xiaoqian Xiao, Ph.D., Dalton Duvio, B.S., Hugh B. Solvason, M.D., Jessica Hawkins, B.A., Austin Guerra, B.A., BooilJo, Ph.D., Kristin S. Raj, M.D., Angela L. Phillips, Ph.D., Fahim Barmak, M.D., James H. Bishop, Ph.D., John P. Coetzee, Ph.D., Charles DeBattista, M.D., Jennifer Keller, Ph.D., Alan F. Schatzberg, M.D., Keith D. Sudheimer, Ph.D., Nolan R. Williams, M.D.
Network effects of Stanford Neuromodulation Therapy (SNT) in treatment-resistant major depressive disorder: a randomized, controlled trial
Summary: Failure to achieve complete remission in treating Major Depressive Disorder (MDD) leads to increased morbidity, relapse rates and suicidality. This study was designed to examine brain functional connectivity changes in treatment-resistant patients (TRD) who participated in a clinical trial of SAINT (Stanford Neuromodulation Therapy). The results demonstrated that 1) functional connectivity changes support improved regulation of emotion and reward processing after SAINT; 2) Amygdala-centered network changes are central to the therapeutic effect of SAINT; and 3) the promise of the relationship between functional connectivity and clinical outcomes and explored any functional connectivity changes. This is the first evidence that the SAINT protocol has downstream effects on brain functional connectivity. This recently published clinical trial demonstrated the high efficacy of SAINT for TRD.
View Authors Jean-Marie Batail, Xiaoqian Xiao, Azeezat Azeez, Claudia Tischler, Ian H. Kratter, James H. Bishop, Manish Saggar, Nolan R. Williams
In these studies SAINT™ has been shown to be effective in the treatment of MDD, with approximately 80-90% of patients achieving remission of depression symptoms following the five-day treatment protocol. Treatment with SAINT™ is safe and well-tolerated according to results, indicating that this new treatment promises to be a rapid and effective treatment for treatment-resistant major depression.
