SAINT Neuromodulation for Postpartum Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) can quickly relieve postpartum depression symptoms. SAINT uses repetitive transcranial magnetic stimulation (rTMS), a non-invasive method applying magnetic fields to the brain, and will be compared to a non-active sham treatment. Women who have experienced depression after childbirth within the last six months and haven't found relief with standard treatments may be suitable candidates. The trial will monitor participants' progress over six months to determine if SAINT is effective, safe, and beneficial for mother-infant bonding. As an unphased trial, participants can contribute to groundbreaking research that may offer new hope for postpartum depression relief.
Do I have to stop taking my current medications for the trial?
The trial requires participants to be on a stable treatment regimen for at least 30 days before enrolling, so you should not stop taking your current medications if they are part of this regimen.
What prior data suggests that SAINT neuromodulation is safe for postpartum depression?
Research shows that the Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) is safe and generally well-tolerated. The FDA has approved SAINT for treating major depressive disorder (MDD) in adults who haven't found relief from other treatments, indicating it has passed certain safety checks for that condition.
Studies have found that SAINT can lead to significant improvement in patients with treatment-resistant depression (TRD), with 80-90% of patients experiencing relief in just a few days. This is encouraging because it suggests the treatment works quickly and effectively.
While all treatments can have side effects, SAINT is reported to be safe and comfortable for most people. This makes it a promising option for those considering joining a clinical trial for postpartum depression.12345Why are researchers excited about this trial?
Researchers are excited about SAINT neuromodulation for postpartum depression because it targets the brain differently compared to standard treatments like antidepressants or talk therapy. While most treatments work by altering brain chemicals over weeks, SAINT directly stimulates the left dorsolateral prefrontal cortex, potentially offering quicker symptom relief. This targeted neuromodulation approach could provide a non-invasive and fast-acting alternative for new mothers struggling with postpartum depression.
What evidence suggests that SAINT could be an effective treatment for postpartum depression?
Studies have shown that the SAINT treatment, a type of repetitive transcranial magnetic stimulation (rTMS), holds great promise for treating depression. Earlier research with patients whose depression resisted other treatments demonstrated dramatic recovery rates of 80-90% with SAINT in just five days or less. This trial will compare Active SAINT Stimulation with Sham SAINT Stimulation for postpartum depression. Specifically for postpartum depression, other studies have found that rTMS can improve symptoms and mental function. In one study, 73.7% of women with postpartum depression recovered after eight weeks of rTMS treatment. These findings suggest that SAINT could be a powerful option for those struggling with postpartum depression.16789
Are You a Good Fit for This Trial?
This trial is for women within six months after giving birth who are struggling with severe postpartum depression that hasn't gotten better with usual treatments. Specific eligibility details aren't provided, but typically participants must meet certain health criteria to join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Blinded Treatment
Participants are randomized to receive 5 days of active SAINT or sham treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment, with additional SAINT offered if symptoms worsen
What Are the Treatments Tested in This Trial?
Interventions
- SAINT
Trial Overview
The study tests the SAINT Neuromodulation System—a type of fast-acting transcranial magnetic stimulation—against a sham (fake) treatment to see if it can quickly reduce symptoms of postpartum depression and improve mother-infant bonding.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Active SAINT stimulation will be applied to the left dorsolateral prefrontal cortex (L-DLPFC)
Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (L-DLPFC).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Magnus Medical
Lead Sponsor
Congressionally Directed Medical Research Programs
Collaborator
Citations
NCT07210255 | SAINT in Postpartum Depression (PPD)
It has demonstrated dramatic remission rates of 80-90% in patients with treatment resistant depression (TRD) in 5 days or fewer of treatment.
Is Transcranial Magnetic Stimulation Effective ...
Nineteen out of 25 women completed the study; 14 participants (73.7%) achieved remission by the end of 8 weeks treatment with TMS. The Bottom Line. All of the ...
Effects of repetitive transcranial magnetic stimulation on ...
Current evidence of RCT showed that rTMS could improve depression symptoms and cognitive function in patients with PPD. Introduction. Postpartum depression(PPD) ...
Repetitive transcranial magnetic stimulation treats ...
Overall, these results revealed a significant reduction in depressive symptoms by the end of Week 2 of treatment. Analyses yielded a medium effect size (r=0.68) ...
5.
womensmentalhealth.org
womensmentalhealth.org/posts/transcranial-magnetic-stimulation-for-perinatal-depression/Transcranial Magnetic Stimulation for Perinatal Depression
In a 2016 multi-center open-label study of 19 patients, 14 achieved remission of PPD from TMS monotherapy with no serious adverse events.
SAINT in Postpartum Depression (PPD) - ClinicalTrials.Veeva
It has demonstrated dramatic remission rates of 80-90% in patients with treatment resistant depression (TRD) in 5 days or fewer of treatment.
September 1, 2022 Magnus Medical, Inc. Susan Noriega VP ...
Note: The clinical performance data for the Magnus Neuromodulation System (MNS) with SAINT. Technology were obtained from a total of 70 ...
Improved Interhemispheric Functional Connectivity in ...
It has been shown to be effective, safe, tolerable, and rapid acting for treating treatment-resistant depression, and may be a valuable tool in ...
Durability of clinical benefit with Stanford Neuromodulation ...
Details on treatment emergent side effects, safety, tolerability, and concomitant medication use have all been detailed in the previously published open-label ...
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