ACTIVE_NOT_RECRUITING

Open Label Optimization Study

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Conditions

Major Depressive DisorderDepressionTreatment Resistant Depression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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®

Official Title

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

Quick Facts

Study Start:2023-04-06
Study Completion:2027-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05819021

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult males or females, 18 and older, who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
  2. 2. Confirmed primary clinical diagnosis of major depressive disorder (MDD) without psychotic features consistent with DSM-V criteria.
  3. 3. No medical conditions that would preclude the safe use of TMS.
  4. 4. Primary psychiatrist has determined TMS to be an appropriate clinical option.
  5. 5. Able to provide consent and comply with all study requirements.
  6. 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. 1. Have any contraindication to TMS (section 2 User Manual).
  2. 2. Have any contraindication to receiving an MRI
  3. 3. Participants with an abnormal brain MRI as determined by PI, study physician or designee.
  4. 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. 5. Treatment dose with cortical depth adjustment is greater than 120% motor threshold and cannot be completed.

Contacts and Locations

Study Locations (Sites)

BrainHealth Solutions
Costa Mesa, California, 92626
United States
LA TMS
Los Angeles, California, 90025
United States
Integral TMS
Sunnyvale, California, 94085
United States
Acacial Research Center
Sunnyvale, California, 94087
United States
Boston Precision Neurotherapeutics
Natick, Massachusetts, 01760
United States
Fermata
Brooklyn, New York, 11249
United States
Seattle Neuropsychiatric Treatment Center
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: Magnus Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-06
Study Completion Date2027-04-15

Study Record Updates

Study Start Date2023-04-06
Study Completion Date2027-04-15

Terms related to this study

Keywords Provided by Researchers

  • Major Depressive Disorder
  • Depression
  • Treatment Resistant Depression

Additional Relevant MeSH Terms

  • Major Depressive Disorder