SAINT in Postpartum Depression (PPD)

Magnus Medical

Status

Enrolling

Conditions

Postpartum Depression (PPD)

Treatments

Device: Sham SAINT Stimulation

Device: SAINT Neuromodulation System

Study type

Interventional

Funder types

Industry

Other U.S. Federal agency

Identifiers

NCT07210255

CLN-0108

CDMRP-PR240070 (Other Grant/Funding Number)

Details and patient eligibility

About

This study is a large, multi-site clinical trial testing whether Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), a fast-acting form of repetitive transcranial magnetic stimulation (rTMS), can more effectively reduce symptoms of postpartum depression (PPD) compared to a sham treatment.

It will enroll 192 women within six months postpartum who are experiencing depression that has not improved with standard care, and will track their progress for up to six months. The trial's main goal is to see if SAINT leads to rapid improvement in depression, while also evaluating its safety, durability of benefit, and impact on mother-infant bonding.

Full description

SAINT combines an accelerated rTMS stimulation protocol with individualized functional connectivity (FC)-based brain targeting. It has demonstrated dramatic remission rates of 80-90% in patients with treatment resistant depression (TRD) in 5 days or fewer of treatment. SAINT is FDA cleared for the treatment of major depressive disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

This is a multi-site, randomized trial to assess SAINT versus sham stimulation for PPD in women who are non-responsive to standard of care treatment. This study will evaluate whether SAINT is superior to placebo in reducing symptoms of depression in PPD among women unresponsive to standard care. Unlike traditional treatments, SAINT is designed to provide rapid relief from depressive symptoms, potentially within just a few days. The rationale for this study is based on the need for a faster, more effective treatment option that can quickly stabilize the mental health of new mothers, allowing them to better care for their infants and themselves.

This study will primarily benefit women who have recently given birth and are struggling with a postpartum depression. These women often face intense emotional distress that can interfere with their ability to bond with their newborns and manage daily responsibilities. By offering a quicker route to recovery, SAINT has the potential to restore these mothers' mental health, enabling them to fully engage in their new role as parents. The study also aims to include a diverse population, ensuring that the benefits of SAINT are generalizable.

There are two phases in this study:

A blinded phase where participants will be randomized to receive 5 days of active SAINT, an accelerated and individualized form of rTMS, or a sham (placebo) treatment.
After the acute treatment, participants will enter the 6 month follow-up phase. During this phase, if participants experience worsening symptoms, they will be offered 1 course of active SAINT treatment. (5 days).

Total study duration for each participant is approximately 7.5 months.

Enrollment

192 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Reproductive Women ages 18-45 at the time of consent.
Diagnosis of non-psychotic Major Depressive Episode (MDE) with peripartum onset as assessed through the Quick Structured Clinical Interview for DSM-5.
0-6 months postpartum.
Must be on a stable treatment as usual (TAU) regimen for 30 days at the time of enrollment (pharmacology and/or psychotherapy).
Severe depression as measured by MADRS ≥25 at screening.
A good candidate for repetitive transcranial magnetic stimulation (rTMS) as determined by a physician.
Participants must be capable of giving informed consent. Participants must be proficient in English in order to comprehend study requirements.
Agree to use effective contraception in the postpartum period for the study duration.
Willing and able to comply with all study procedures, complete required assessments and visits, and be available for the duration of the study.

Exclusion criteria

Participant has attempted suicide in the last 6 months and/or expressed suicidal ideation with intent as determined by physician assessment at the time of enrollment.
Score of 6 on MADRS item 10 (high rating of suicidal ideation) at screening.
Participant has active psychosis per investigator assessment.
Participant with a primary lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder and/or obsessive-compulsive disorder.
Participant has an active eating disorder or substance use disorder in the past 6 months and/or has a positive urine toxicity screen that the Principal Investigator (PI) deems exclusionary.
Participant is on a GABA-A agonist or modulator.
Participant has a history of untreated or insufficiently treated sleep apnea.
Participant has a history of significant neurologic disease, including developmental disability, dementia, Parkinson's or Huntington's disease, brain tumor, unexpected seizure/epilepsy disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma.
Any untreated major somatic illness such as hypertension/cardiovascular disease/diabetes/endocrine disorders etc.
Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion).
Contraindications to MRI (e.g., ferromagnetic metal in their body).
Currently pregnant.
History of receiving rTMS for any reason, as this may compromise blinding.