No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 45
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
192 (estimated)
Sponsor
Magnus Medical · Industry
Who this trial is looking for
This trial is looking for women aged 18-45 who are experiencing postpartum depression. Participants will undergo a treatment called SAINT and be monitored for up to one year.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman aged 18-45.
I have been diagnosed with postpartum depression.
I am 0-12 months postpartum.
I have severe depression as measured by MADRS.
I can give informed consent.
I will use effective contraception during the study.
I am willing to attend all study visits.
You may not be able to join if
I have attempted suicide in the last 6 months.
I currently have suicidal thoughts.
I have active psychosis.
I have a history of bipolar disorder or schizophrenia.
I have an active eating disorder or substance use disorder.
I have untreated sleep apnea.
I have significant neurologic disease.
I am currently pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Reproductive Women ages 18-45 at the time of consent.
2. Diagnosis of non-psychotic Major Depressive Episode (MDE) with peripartum onset as assessed through the Quick Structured Clinical Interview for DSM-5.
3. 0-12 months postpartum. Participants must be 0-12 months postpart…
Inclusion Criteria:
1. Reproductive Women ages 18-45 at the time of consent.
2. Diagnosis of non-psychotic Major Depressive Episode (MDE) with peripartum onset as assessed through the Quick Structured Clinical Interview for DSM-5.
3. 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.
4. If currently taking an antidepressant medication and/or receiving psychotherapy must be on a stable regimen for 30 days at the time of enrollment.
5. Severe depression as measured by MADRS ≥20 at screening.
6. A good candidate for repetitive transcranial magnetic stimulation (rTMS) as determined by a physician.
7. Participants must be capable of giving informed consent. Participants must be proficient in English in order to comprehend study requirements.
8. Agree to use effective contraception in the postpartum period for the study duration.
9. 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:
1. 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.
2. Score of 6 on MADRS item 10 (high rating of suicidal ideation) at screening.
3. Participant has active psychosis per investigator assessment.
4. Participant with a primary lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder and/or obsessive-compulsive disorder.
5. 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.
6. 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.
7. Participant has a history of untreated or insufficiently treated sleep apnea.
8. 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.
9. Any untreated major somatic illness such as hypertension/cardiovascular disease/diabetes/endocrine disorders etc.
10. Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion).
11. Contraindications to MRI (e.g., ferromagnetic metal in their body).
12. Currently pregnant.
13. History of receiving rTMS for any reason, as this may compromise blinding.
Contacts
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