A Randomized Controlled Multi-site Trial Evaluating SAINT for Postpartum Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 192
- Locations
- 7
- Primary Endpoint
- The change in depression symptom severity, assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to 5 days post-treatment, which will be compared between the acute active SAINT and sham arms.
Study Overview
Brief Summary
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 12 months postpartum who are experiencing depression, and will track their progress for up to 12 months. The trial's main goal is to see if SAINT leads to reduction in depression severity in women with postpartum depression.
Detailed 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. This study will evaluate whether SAINT is superior to placebo in reducing symptoms of depression in women with PPD. 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 either 5 days of active SAINT, an accelerated and individualized form of rTMS, or a sham (placebo).
- After the blinded phase, participants will enter the 6 month follow-up phase. During this phase, if participants experience worsening symptoms, they may be eligible to receive 1 course of active SAINT treatment. (5 days).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Study monitors, SAINT treaters, Research coordinators.
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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-
- •0-12 months postpartum. Participants must be 0-12 months postpartum at screening and remain within 12 months postpartum at the 5-day post-treatment visit.
- •If currently taking an antidepressant medication and/or receiving psychotherapy must be on a stable regimen for 30 days at the time of enrollment.
- •Severe depression as measured by MADRS ≥20 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 using any exclusionary medications: high dose of benzodiazepines (>2mg lorazepam daily equivalent and/or >3 times per week) or medications that would interfere with treatment with TMS as per PI or designee discretion.
- •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.
Arms & Interventions
Sham SAINT Stimulation
Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (L-DLPFC).
Intervention: Sham SAINT Stimulation (Device)
Active SAINT Stimulation
Active SAINT stimulation will be applied to the left dorsolateral prefrontal cortex (L-DLPFC)
Intervention: SAINT Neuromodulation System (Device)
Outcomes
Primary Outcomes
The change in depression symptom severity, assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to 5 days post-treatment, which will be compared between the acute active SAINT and sham arms.
Time Frame: Baseline and 5 days post-acute treatment
The change in depression symptom severity will be measured by Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to 5 days post-treatment. Outcomes will be compared between the acute active SAINT and sham arms. Scores range from 0-60 (10 questions, each scored 0-6) with higher scores indicating a worsening of depressive symptoms and lower scores indicating better outcomes.
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: Baseline and 5 days post-acute treatment
The change in depression symptom severity will be measured by Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to 5 days post-treatment. Outcomes will be compared between the acute active SAINT and sham arms. Scores range from 0-60 (10 questions, each scored 0-6) with higher scores indicating a worsening of depressive symptoms and lower scores indicating better outcomes.
Secondary Outcomes
No secondary outcomes reported