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OLO Clinical Research Program

Now Enrolling

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.

For clinical study sites, additional OLO study information may be found here.