Phase
Condition
N/ATreatment
SAINT Neuromodulation System
Sham SAINT Stimulation
Clinical Study ID
Ages 18-45 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Reproductive Women ages 18-45 at the time of consent.
Diagnosis of non-psychotic Major Depressive Episode (MDE) with peripartum onset asassessed through the Quick Structured Clinical Interview for DSM-5.
0-12 months postpartum. Participants must be 0-12 months postpartum at screening andremain within 12 months postpartum at the 5-day post-treatment visit.
If currently taking an antidepressant medication and/or receiving psychotherapy mustbe 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) asdetermined by a physician.
Participants must be capable of giving informed consent. Participants must beproficient in English in order to comprehend study requirements.
Agree to use effective contraception in the postpartum period for the studyduration.
Willing and able to comply with all study procedures, complete required assessmentsand visits, and be available for the duration of the study.
Exclusion
Exclusion Criteria:
Participant has attempted suicide in the last 6 months and/or expressed suicidalideation with intent as determined by physician assessment at the time ofenrollment.
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 6months 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 wouldinterfere 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 developmentaldisability, dementia, Parkinson's or Huntington's disease, brain tumor, unexpectedseizure/epilepsy disorder, subdural hematoma, multiple sclerosis, or history ofsignificant head trauma.
Any untreated major somatic illness such as hypertension/cardiovasculardisease/diabetes/endocrine disorders etc.
Contraindications to receiving rTMS (e.g., metal in head, history of seizure, knownbrain 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.
Study Design
Study Description
Connect with a study center
UMass Chan Medical School
Worcester 4956184, Massachusetts 6254926 01655
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
United StatesActive - Recruiting
The Medical School of South Carolina (MUSC)
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
The Medical University of South Carolina (MUSC)
Charleston 4574324, South Carolina 4597040 29425
United StatesActive - Recruiting
University of Texas at Austin
Austin 4671654, Texas 4736286 78712
United StatesSite Not Available
University of Texas at Austin, Dell Medical School, Health Discovery Building
Austin 4671654, Texas 4736286 78712
United StatesActive - Recruiting

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