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Major Depressive DisorderPhase 2/3NCT06462820

SAINT for MDD in an Inpatient Setting Follow-on

A Phase 2/3 study testing Active SAINT Stimulation in people with Major Depressive Disorder and Major Depressive Episode, run by Magnus Medical at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Randomized, multi-site, sham-controlled, double-blinded study Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Active SAINT Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2 participants
Where
4 sitesUnited States
Study dates
30 Jun 2024to 6 Mar 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults of all genders between the ages of 18 and 75 years at the time of screening, who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode
  • Concurrently enrolled in the NIH multi-site trial titled "The Effects of SAINT® Neuromodulation System on Explicit and Implicit Suicidal Cognition"
  • Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires/follow instructions during fMRI assessments and SAINT treatments
  • Stated willingness to comply with all study procedures including availability for the duration of the study and to communicate with study personnel about adverse events and other clinically important information
  • 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)
  • 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)
Show all 13Show fewer
  • Endorses clinically significant explicit suicidal cognitions (score ≥ 9 on the M-SSI and score ≥ 6 on the BSS self-report)
  • MADRS score of ≥20 at screening (visit 1)
  • rTMS/iTBS naive
  • Access to ongoing psychiatric care before and after completion of the study
  • Access to clinical rTMS after hospital discharge
  • In good general health, as evidenced by medical history
  • For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation. Must have a negative urine pregnancy test prior to enrollment

Who cannot join

  • Pregnancy as confirmed by a positive urine pregnancy test
  • The presence or diagnosis of a prominent anxiety disorder, personality disorder, or dysthymia which in the Investigator's opinion is predominant to MDD
  • Depressed mood/dysphoria as a result of an illness other than MDD (e.g. gender dysphoria)
  • Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation)
  • Current mania or psychosis
  • A history of Bipolar Affective Disorder or Primary Psychotic Disorder
Show all 20Show fewer
  • Autism Spectrum disorder or Intellectual Disability
  • A diagnosis of obsessive-compulsive disorder (OCD)
  • Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal
  • Urine screening test positive for illicit substances
  • Any history of ECT (greater than 8 sessions) without meeting responder criteria
  • Recent (during the current depressive episode) or concurrent use of a rapid acting antidepressant agent (i.e., ketamine or a course of ECT)
  • History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, unexpected seizure/epilepsy disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma
  • Untreated or insufficiently treated endocrine disorder
  • Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion)
  • Contraindications to MRI (ferromagnetic metal in their body)
  • Any current or past history of any physical condition which, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation
  • Treatment with another investigational drug or other intervention within the study period
  • Depth-adjusted SAINT® treatment dose > 65% maximum stimulator output (MSO)
  • Any other condition deemed by the PI to interfere with the study or increase risk to the participant

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Texas, Ausin - Department of Psychiatry and Behavioral Sciences

    Austin, Texas, 78712

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Iowa

    Iowa City, Iowa, 52242

  • Weill Cornell Medicine

    Manhattan, New York, 10021

Other trials in United States

About this study

Official title: SAINT® Neuromodulation System for the Treatment of Depression in an Inpatient Setting

Randomized, multi-site, sham-controlled, double-blinded study

Read the detailed description

This multi-site, double-blind, randomized, sham-controlled mechanistic trial aims to test the effects of Magnus Neuromodulation System (MNS) with Stanford Accelerated Intermittent Neuromodulation Therapy (SAINT) Technology for the treatment of depression and suicidal cognitions in psychiatrically hospitalized patients with Major Depressive Disorder (MDD) and active suicidal ideation (SI). This will be accomplished by applying the MNS with SAINT protocol (10 applications per day to a customized target within the left dorsolateral prefrontal cortex (L-DLPFC) identified with fMRI for five consecutive days) and measuring changes in depressive symptoms and suicidality at baseline and immediate-post visit.

Th clinical hypothesis is that participants receiving per-protocol active SAINT stimulation will demonstrate a significant difference in Montgomery-Asberg Depression Rating Scale (MADRS) scores/remission rates at the immediate post treatment visit, compared to those who receive per protocol sham SAINT stimulation.

The primary objective of this study is to determine the efficacy of active SAINT vs. sham SAINT in reducing symptoms of depression as measured by the MADRS.

The study will enroll approximately 100 participants and employ a two-arm design with 50 subjects per arm. The target population is adults of all genders and ethnicities who are between 18 and 75 years of age with a diagnosis of treatment-resistant MDD experiencing a current Major Depressive Episode, with active suicidal ideation, and who are otherwise in good general health. Participants must be without contraindications to Magnetic Resonance Imaging (MRI) or transcranial magnetic stimulation (TMS) and must be able to attend all study visits.

This study will deliver both active and sham SAINT via a MagPro X100 edition (MagVenture, Skovlunde, Denmark) TMS device equipped with a Cool-B65 A/P coil. The stimulation paradigm consists of 10 daily sessions (50 total over 5-days) of MNS with SAINT stimulation (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex). An operator entered code (derived from the study EDC) will instruct the device to deliver active or sham magnetic stimulation.

Being tested
Active SAINT Stimulation, Sham SAINT Stimulation
Keywords
Suicidality, Neuromodulation, Transcranial magnetic stimulation, Depression, Intermittent theta burst stimulation
Medical subject headings
Depressive Disorder, Major, Suicidal Ideation, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active SAINT StimulationDevice

    Participants who are randomly assigned to this group will receive active SAINT targeted to the left DLPFC. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth).

    Stimulation will be delivered using the Magventure Magpro X100 TMS system with the Cool-B65 A/P coil.

  • Sham SAINT StimulationDevice

    Participants who are randomly assigned to this group will receive sham stimulation targeted to the left DLPFC.

    Sham stimulation will be delivered using the Magventure Magpro X100 TMS system with the Cool-B65 A/P coil.

Study groups in NCT06462820
Study groupRoleWhat they receive
Active SAINT StimulationActive comparatorActive SAINT stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC)
Receives: Device: Active SAINT Stimulation
Sham StimulationSham comparatorSham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC)
Receives: Device: Sham SAINT Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Montgomery-Asberg Depression Rating Scale (MADRS) Remission Rates

    Ten item diagnostic questionnaire which psychiatrists use to measure the severity of depressive symptoms in patients with mood disorders.

    We will assess the difference in MADRS scores/remission rates between the per-protocol active SAINT group compared to those who received per-protocol sham treatment at the immediate post treatment visit.

    Measured: Screening/Baseline, Immediate Post Visit

Secondary outcomes (3)

  1. Modified Scale for Suicidal Ideation (M-SSI)

    A revised version of the Scale for Suicidal Ideation (SSI; Beck et al., 1979). The MSSI is an 18 item scale that contains 13 items from the SSI and 5 additional items.

    We will assess the mean change in the M-SSI from baseline to immediate post treatment visits between the per-protocol active SAINT group compared to those who received per-protocol sham treatment.

    Measured: Screening/Baseline, Immediate Post Visit

  2. Columbia Suicide Severity Rating Scale (C-SSRS)

    We will use both the Lifetime and the Since Last Visit versions of the C-SSRS to assess suicidality from baseline to immediate post treatment between the per-protocol active SAINT group compared to those who received per-protocol sham treatment.

    Measured: Screening/Baseline, Immediate Post Visit

  3. Montgomery-Asberg Depression Rating Scale (MADRS) Response Rates

    We will assess the difference in MADRS response rates (reduction >50% of MADRS baseline score) between the per-protocol active SAINT group compared to those who received per-protocol sham treatment at the immediate post treatment visit.

    Measured: Screening/Baseline, Immediate Post Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2024
  2. Study start30 Jun 2024
  3. Primary completion6 Mar 2025
  4. Study completion6 Mar 2025

Why it stopped: Funding discontinued.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will receive either active or sham stimulation to the DLPFC. Patients will be randomized to either condition with a 50:50 chance.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06462820
Sponsor's protocol ID
CLN-0106
Status last verified
Oct 2024
First submitted
12 Jun 2024
Last updated
24 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Cole EJ, Phillips AL, Bentzley BS, Stimpson KH, Nejad R, Barmak F, Veerapal C, Khan N, Cherian K, Felber E, Brown R, Choi E, King S, Pankow H, Bishop JH, Azeez A, Coetzee J, Rapier R, Odenwald N, Carreon D, Hawkins J, Chang M, Keller J, Raj K, DeBattista C, Jo B, Espil FM, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022 Feb;179(2):132-141. doi: 10.1176/appi.ajp.2021.20101429. Epub 2021 Oct 29.

    PubMed 34711062

  • Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7.

    PubMed 32252538

  • Williams NR, Sudheimer KD, Bentzley BS, Pannu J, Stimpson KH, Duvio D, Cherian K, Hawkins J, Scherrer KH, Vyssoki B, DeSouza D, Raj KS, Keller J, Schatzberg AF. High-dose spaced theta-burst TMS as a rapid-acting antidepressant in highly refractory depression. Brain. 2018 Mar 1;141(3):e18. doi: 10.1093/brain/awx379. No abstract available.

    PubMed 29415152

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Active SAINT Stimulation in people with Major Depressive Disorder and Major Depressive Episode, run by Magnus Medical at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Funding discontinued.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montgomery-Asberg Depression Rating Scale (MADRS) Remission Rates (time frame: Screening/Baseline, Immediate Post Visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06462820, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.

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