Open Label Optimization Study

Launched by MAGNUS MEDICAL · Apr 17, 2023

Keywords

ClinConnect Summary

This clinical trial, called an Open Label Optimization Study, is looking at a new treatment option for people with Major Depressive Disorder (MDD) who haven’t found relief from current antidepressant medications. The study aims to see how effective a treatment called SAINT® is in helping improve symptoms of depression. Participants will receive 10 sessions of this treatment over 5 days, from Monday to Friday.

To be eligible for the study, participants must be adults aged 18 and older who have not had satisfactory improvement from other antidepressants. They should also have a confirmed diagnosis of MDD without any psychotic features, and their psychiatrist must agree that this new treatment is suitable for them. Participants need to be able to give consent and follow all study requirements, including a negative pregnancy test and the use of effective birth control during treatment. It’s important to note that individuals with certain medical conditions or risks may not be able to participate. If you decide to take part, you can expect a supportive environment where your progress will be closely monitored throughout the treatment period.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• 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 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.