SAINT for MDD in an Inpatient Setting Follow-on

NCT06462820 | Terminated Phase 2 DMC FDA Device

• 1 other identifier: CLN-0106
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Major Depressive Disorder; Major Depressive Episode; Suicidal Ideation

Keywords

Suicidality; Neuromodulation; Transcranial magnetic stimulation; Depression; Intermittent theta burst stimulation

Outcome Measures

Primary Outcomes (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.

  Screening/Baseline, Immediate Post Visit

Secondary Outcomes (3)

• Modified Scale for Suicidal Ideation (M-SSI)

  Screening/Baseline, Immediate Post Visit

• Columbia Suicide Severity Rating Scale (C-SSRS)

  Screening/Baseline, Immediate Post Visit

• Montgomery-Asberg Depression Rating Scale (MADRS) Response Rates

  Screening/Baseline, Immediate Post Visit

Study Arms (2)

Active SAINT Stimulation

ACTIVE COMPARATOR

Active SAINT stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC)

Device: Active SAINT Stimulation

Sham Stimulation

SHAM COMPARATOR

Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC)

Device: Sham SAINT Stimulation

Interventions

Active SAINT Stimulation DEVICE

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.

Active SAINT Stimulation

Sham SAINT Stimulation DEVICE

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.

Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Magnus Medical: lead

Study Sites (4)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Weill Cornell Medicine

Manhattan, New York, 10021, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

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

Austin, Texas, 78712, United States

Location

Related Publications (3)

• 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.

  PMID: 34711062 BACKGROUND

• 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.

  PMID: 32252538 BACKGROUND

• 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.

  PMID: 29415152 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Suicidal Ideation; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Brandon Bentzley, MD

  Magnus Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will receive either active or sham stimulation to the DLPFC. Patients will be randomized to either condition with a 50:50 chance.

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: June 30, 2024
• Primary Completion: March 6, 2025
• Study Completion: March 6, 2025
• Last Updated: March 24, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)