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New treatment option for Postpartum Depression (PPD)
Official title SAINT in Postpartum Depression (PPD)
ClinicalTrials.gov ID: NCT07210255
What this study is testing
- What it's testing
- 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 that has not improved with standard care, and will track their progress for up to 12 months.
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- 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.
- 0-12 months postpartum. Participants must be 0-12 months postpartum at screening and remain within 12 months postpartum at the 5-day post-treatment...
- 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.
You likely can't join if
- Participant has attempted suicide in the last 6 months and/or expressed suicidal ideation with intent as determined by physician assessment at the...
- 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...
- Participant is using any exclusionary medications: high dose of benzodiazepines (\>2mg lorazepam daily equivalent and/or \>3 times per week) or...
See the full eligibility 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.
- 0-12 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Worcester, Massachusetts, United States
- New York, New York, United States
- Charleston, South Carolina, United States
- Austin, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Worcester, Massachusetts, United States; New York, New York, United States; Charleston, South Carolina, United States; Austin, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.