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Neuromodulation

Accelerated Brain Stimulation for Depression (SAINT®SC Trial)

Phase 2 & 3

Recruiting

Led By David Spiegel, MD

Research Sponsored by Magnus Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female, between the ages of 18 and 75 years at the time of screening

rTMS/iTBS naive

Must not have

Depth-adjusted aiTBS treatment dose > 65% maximum stimulator output (MSO)

Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline (day 0) and at post-inpatient treatment completion (day 2-7)

Summary

This trial tests a magnetic pulse therapy on adults with severe depression and suicidal thoughts. The therapy targets a specific brain area to change brain communication, aiming to reduce suicidal thoughts and improve mood.

Who is the study for?

Adults aged 18-75 with major depressive disorder or bipolar II experiencing a current major depressive episode, who have not responded well to previous treatments. Participants must be in good health, avoid pregnancy, caffeine, alcohol and tobacco during the trial. They should also be able to understand English and provide consent.

What is being tested?

The study is testing an accelerated form of brain stimulation therapy called SAINT against sham (fake) stimulation for its effects on suicidal thoughts in patients with severe depression. The goal is to see if this intensive treatment can change how the brain processes these thoughts.

What are the potential side effects?

Possible side effects from theta-burst stimulation may include discomfort at the stimulation site, headache, lightheadedness, seizures (rare), or temporary hearing changes due to the noise of the machine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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I have never had rTMS or iTBS treatments.

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I have been diagnosed with MDD or BAD-II and am currently experiencing a major depressive episode.

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My medical records show I have moderate to severe treatment-resistant condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My treatment's intensity is more than 65% of the maximum level.

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I sleep at least 5 hours each night.

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I haven't used rapid acting antidepressants like ketamine or had ECT recently.

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I have a history of serious brain or nerve conditions.

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I have a hormone-related condition that is untreated or not fully treated.

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I have been diagnosed with obsessive-compulsive disorder.

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I've had more than 8 ECT sessions without improvement.

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I don't have metal in my head, a history of seizures, or known brain lesions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline (day 0) and at post-inpatient treatment completion (day 2-7)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline (day 0) and at post-inpatient treatment completion (day 2-7)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (day 0) and at post-inpatient treatment completion (day 2-7) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the neural network underlying Explicit Suicidal Cognition (ESC) as measured by resting state functional connectivity changes in subgenual anterior cingulate (sgACC) and the default mode network (DMN).

Secondary study objectives

Change in the neural network underlying Implicit Suicidal Cognition (ISC) as measured by resting state functional connectivity changes in dorsolateral prefrontal cortex (DLPFC) and the anterior cingulate cortex (ACC).

Other study objectives

Change in the neural networks underlying depression, hopelessness and anhedonia as measured by resting state functional connectivity changes of sgACC and medial orbitofrontal cortex (mOFC).