Open Label Optimization Study

Description

The goal of this observational study is to demonstrate effectiveness in the treatment of Major Depressive Disorder The primary objective is to assess the effectiveness in the treatment of Major Depressive Disorder using the CGI-I at the end of the treatment Participants will receive 10 treatments per day for 5 days (M-F) of SAINT®

Conditions

Major Depressive Disorder

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Study Overview

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Study Details

Study overview

The goal of this observational study is to demonstrate effectiveness in the treatment of Major Depressive Disorder The primary objective is to assess the effectiveness in the treatment of Major Depressive Disorder using the CGI-I at the end of the treatment Participants will receive 10 treatments per day for 5 days (M-F) of SAINT®

An Open Label Optimization Study to Assess the Effectiveness of the SAINT® Neuromodulation System (NMS) to Treat Major Depressive Disorder

Open Label Optimization Study

Condition
Major Depressive Disorder
Intervention / Treatment

-

Contacts and Locations

Costa Mesa

BrainHealth Solutions, Costa Mesa, California, United States, 92626

Los Angeles

LA TMS, Los Angeles, California, United States, 90025

Sunnyvale

Integral TMS, Sunnyvale, California, United States, 94085

Sunnyvale

Acacial Research Center, Sunnyvale, California, United States, 94087

Natick

Boston Precision Neurotherapeutics, Natick, Massachusetts, United States, 01760

Brooklyn

Fermata, Brooklyn, New York, United States, 11249

Seattle

Seattle Neuropsychiatric Treatment Center, Seattle, Washington, United States, 98104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Adult males or females, 18 and older, who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
  • 2. Confirmed primary clinical diagnosis of major depressive disorder (MDD) without psychotic features consistent with DSM-V criteria.
  • 3. No medical conditions that would preclude the safe use of TMS.
  • 4. Primary psychiatrist has determined TMS to be an appropriate clinical option.
  • 5. Able to provide consent and comply with all study requirements.
  • 6. Negative pregnancy test at the intended time of SAINT™ 5-day acute course treatment and agreement to use effective birth control during SAINT® acute therapy.
  • 1. Have any contraindication to TMS (section 2 User Manual).
  • 2. Have any contraindication to receiving an MRI
  • 3. Participants with an abnormal brain MRI as determined by PI, study physician or designee.
  • 4. Deemed by the PI, study physician or designee to be a high risk of suicide or has made a suicide attempt within the last 6 months.
  • 5. Treatment dose with cortical depth adjustment is greater than 120% motor threshold and cannot be completed.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Magnus Medical,

Study Record Dates

2027-04-15