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Behavioural Intervention

SAINT Stimulation for Depression

Phase 2 & 3
Recruiting
Research Sponsored by Magnus Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Medical records confirming a history of moderate to severe treatment-resistance as defined by a score of 7-14 on the Maudsley Staging Method153 (MSM)
Currently diagnosed with Major Depressive Disorder (MDD) and meets criteria for a current Major Depressive Episode (MDE) according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5)
Must not have
Untreated or insufficiently treated endocrine disorder
Current mania or psychosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening/baseline, immediate post visit

Summary

This trial tests a device that uses magnetic pulses to help adults with severe depression and suicidal thoughts who haven't improved with standard treatments. The device targets a specific brain area to improve mood and reduce suicidal thoughts. This method has shown promising results as an alternative to other treatments for severe depression.

Who is the study for?
Adults aged 18-75 with Major Depressive Disorder and a current major episode, who haven't responded well to antidepressants. Must not have had certain brain treatments or conditions, be drug-free, agree to use effective contraception, and commit to the study's duration.
What is being tested?
The trial is testing SAINT stimulation versus a sham (fake) procedure in hospitalized patients with depression. It's randomized and double-blinded so neither participants nor researchers know who gets real treatment until after the study.
What are the potential side effects?
Specific side effects are not listed for SAINT stimulation but may include discomfort at the stimulation site, headache, lightheadedness, or seizures; however these are general rTMS-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My medical records show I have moderate to severe treatment-resistant depression.
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I have been diagnosed with Major Depressive Disorder and am currently experiencing a major depressive episode.
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I have never undergone rTMS or iTBS treatments.
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I can read and understand English well enough to follow study instructions and provide consent.
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I am between 18 and 75 years old and my depression hasn't improved with medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a hormone disorder that is untreated or not fully treated.
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I am not experiencing mania or psychosis.
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I have been diagnosed with Bipolar Disorder or a Psychotic Disorder.
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I have used ketamine or had ECT for depression recently.
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I have been diagnosed with obsessive-compulsive disorder.
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I don't have metal implants in my head, a history of seizures, or known brain lesions.
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I sleep at least 5 hours each night.
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I've had more than 8 ECT sessions without improvement.
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I have a history of serious brain or nerve conditions.
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My treatment requires a high intensity setting above 65%.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening/baseline, immediate post visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening/baseline, immediate post visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Montgomery-Asberg Depression Rating Scale (MADRS) Remission Rates
Secondary study objectives
Columbia Suicide Severity Rating Scale (C-SSRS)
Modified Scale for Suicidal Ideation (M-SSI)
Montgomery-Asberg Depression Rating Scale (MADRS) Response Rates

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active SAINT StimulationActive Control1 Intervention
Active SAINT stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC)
Group II: Sham StimulationPlacebo Group1 Intervention
Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC)

Find a Location

Who is running the clinical trial?

Magnus MedicalLead Sponsor
4 Previous Clinical Trials
1,150 Total Patients Enrolled
Brandon Bentzley, MDStudy DirectorMagnus Medical
1 Previous Clinical Trials
100 Total Patients Enrolled
~67 spots leftby Dec 2025
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