Open Label Optimization Study

Last updated: April 25, 2025
Sponsor: Magnus Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Affective Disorders

Depression (Adult And Geriatric)

Treatment

SAINT® Neuromodulation System (NMS)

Clinical Study ID

NCT05819021
CLN-0107
  • Ages > 18
  • All Genders

Study Summary

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®

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult males or females, 18 and older, who have failed to receive satisfactoryimprovement from prior antidepressant medication in the current episode.

  2. Confirmed primary clinical diagnosis of major depressive disorder (MDD) withoutpsychotic 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 treatmentand agreement to use effective birth control during SAINT® acute therapy.

Exclusion

Exclusion Criteria:

  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 ordesignee.

  4. Deemed by the PI, study physician or designee to be a high risk of suicide or hasmade a suicide attempt within the last 6 months.

  5. Treatment dose with cortical depth adjustment is greater than 120% motor thresholdand cannot be completed.

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: SAINT® Neuromodulation System (NMS)
Phase:
Study Start date:
April 06, 2023
Estimated Completion Date:
April 15, 2027

Study Description

This is a prospective, multi-center, open-label study.

Up to 1000 adult subjects, in a major depressive episode, who have failed to receive satisfactory improvement from a prior antidepressant medication in the current episode, are eligible to participate in this study if they are deemed to be appropriate candidates for TMS.

Overall study duration is expected to be approximately 4 years. The study duration per subject is anticipated to be approximately 1 year.

Hypothesis: The SAINT® Neuromodulation System will demonstrate effectiveness in the treatment of MDD as measured by CGI-I at the end of the treatment (cessation of stimulation).

Connect with a study center

  • BrainHealth Solutions

    Costa Mesa, California 92626
    United States

    Active - Recruiting

  • LA TMS

    Los Angeles, California 90025
    United States

    Site Not Available

  • Acacial Research Center

    Sunnyvale, California 94087
    United States

    Completed

  • Integral TMS

    Sunnyvale, California 94085
    United States

    Active - Recruiting

  • Boston Precision Neurotherapeutics

    Natick, Massachusetts 01760
    United States

    Site Not Available

  • Fermata

    Brooklyn, New York 11249
    United States

    Active - Recruiting

  • Seattle Neuropsychiatric Treatment Center

    Seattle, Washington 98104
    United States

    Active - Recruiting

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