This study is being conducted to better understand postpartum depression and to evaluate the safety and effectiveness of an investigational form of transcranial magnetic stimulation (TMS) called SAINT® for postpartum depression.

You may be eligible for this study if you meet the following criteria: 

• Ages 18-45
• Women 0-12 months postpartum
• Experiencing postpartum depression
• If receiving treatment for depression, willing to keep regimen stable for 4 weeks prior to study entry
• Not currently pregnant
• Willing to use a medically accepted birth control method, if applicable
• No history of neurological conditions (e.g., Alzheimer’s, MCI, Parkinson’s)
• No history of bipolar disorder
• No history of schizophrenia or related condition
• No current primary diagnosis of obsessive-compulsive disorder
• Able to undergo TMS (e.g., no implanted medical devices, unstable heart conditions, metal in head, history of seizure, known brain lesion)
• Able to undergo an MRI (e.g., no non-removable metal objects in body or claustrophobia)
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If you choose to participate, the study will last about 7.5 months and includes a screening visit, a baseline visit, 5 consecutive days of study treatment, and virtual follow-up visits.

Screening Visit (about 90 minutes):

• Review and sign the consent form.
• Answer questions about your medical history, mental health, medications, and previous treatments.
• Complete questionnaires to determine if you are eligible.
• Schedule a virtual mental health assessment with an independent evaluator.

Baseline Visit:

• Complete a 45-minute MRI scan.
• Complete thinking and memory activities.
• Provide a urine sample for pregnancy and drug screening.
• Complete questionnaires about your mood and mental health.

Treatment Week:

• Attend the study site Monday through Friday (about 8:00 a.m.–6:00 p.m.) for 5 consecutive days.
• Receive 10 brief investigational SAINT® transcranial magnetic stimulation (TMS) sessions each day, with one treatment every hour.
• Complete short mood questionnaires at the end of each day.

Follow-Up:

• Complete virtual follow-up visits for 6 months, including visits 5 days post-treatment, 2 weeks, 1 month, 3 months, and 6 months after treatment, along with brief online questionnaires every 2 weeks between visits.

Some participants whose symptoms do not improve or worsen may be eligible for an optional second treatment week between 1 and 5 months after the first treatment.

This therapy has not been cleared by the FDA for use in postpartum depression. The safety and effectiveness of SAINT for postpartum depression have not yet been established.

Participants may receive up to $450 in compensation for completing study visits. Transportation support, including reimbursement for public transportation or car services, may be available. During the treatment week, support for meals, childcare, and, in some cases, housing may also be available to help make participation easier.

There is no cost for you to participate in our research study.