An interventional study of Transcranial Magnetic Stimulation in Perinatal Depression, Post Partum Depression and Major Depressive Disorder, sponsored by Brigham and Women's Hospital. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Other
We are studying a treatment for depression called accelerated Transcranial Magnetic Stimulation (TMS) among pregnant and postpartum individuals. TMS is a focal, non-invasive form of brain stimulation that is cleared by the Food and Drug Administration for depression. Typically, traditional TMS involves daily treatments for 6-8 weeks. In this study, we will offer an accelerated form of TMS that involves multiple daily treatments for 5 days.
Perinatal depression is underdiagnosed, undertreated, and understudied. Approximately one in five individuals will experience perinatal depression, which spans from conception to one year after birth. Untreated perinatal depression increases the risk of stillbirth, preterm birth, substance abuse, parental suicide, and developmental delay. There are limited empirical data to guide treatment of perinatal depression. Psychotherapy can be effective for mild-to-moderate depression, but it is slow acting and difficult to access. Antidepressants show inconsistent benefits and safety; moreover, patients report feeling anxious or guilty about taking them.
Transcranial magnetic stimulation (TMS) is FDA cleared treatment for major depressive disorder, adolescent depression, late life depression, and anxious depression. It has also shown promise as a safe and effective biological intervention for perinatal depression for both the mother and fetus. One of the most exciting new developments in neurostimulation is accelerated intermittent theta burst stimulation (iTBS), a TMS protocol that involves multiple daily treatments rather than once daily treatment. A specific accelerated TMS protocol called Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) was FDA cleared in September 2022 because of its rapid and robust antidepressant effects. In an open-label study (n=21), SNT significantly reduced depression in one day and yielded 90.5% remission after five days. Importantly, there is no evidence that accelerated TMS protocols pose more risk than conventional TMS protocols that have a strong safety profile.
While SNT is a potential breakthrough treatment, it has not been tested in peripartum individuals. Accelerated iTBS may expedite depressive symptom improvement and reduce the need for pharmacotherapy for individuals struggling with perinatal depression. If tolerable and efficacious, this treatment modality may increase the viable treatment options available to peripartum women with depressive symptoms.
In this pilot trial, patients who are currently pregnant or postpartum with treatment-resistant depression (n=12) will receive a modified SNT with neuronavigation. Treatment site location will be guided by MRI when possible given the promising internal findings highlighted above. However, if neuroimaging is not chosen by the patient, unsafe for the patient for any reason, or not tolerable for the patient, we will offer treatment with scalp-based measurement (i.e., TMS targeting based on Beam F3 method). Overall, this study is critically important for informing the viability of future accelerated iTBS trials in a peripartum population and may shape the future of affective treatment options in this patient group.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 24 is below the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
10 iTBS treatment sessions per day (18,000 pulses/day) for 5 consecutive days (90,000 pulses total) to the dorsolateral prefrontal cortex (DLPFC). In the unlikely event that a participant is late for an hourly treatment, then the treatment will be delayed accordingly. The minimum gap between treatments will be 25 minutes. Each iTBS treatment will consist of 60 cycles of 10 bursts of three pulses at 50 Hz delivered in 2-second trains (5 Hz) with an 8-second intertrain interval. Stimulation will be delivered at 90% resting motor threshold (rMT), adjusted for depth of the identified functional connectivity target or based on traditional scalp measurements.
Device: Transcranial Magnetic Stimulation
Non-invasive form of brain stimulation.
Also known as: TMS, Accelerated intermittent theta burst stimulation, aiTBS
Tolerability as measured by ratings of the Client Satisfaction Questionnaire (CSQ-8)
The CSQ-8 asks individuals about their overall experience with aTMS.Higher scores indicate a greater level of tolerability. We hypothesize that participants will report high levels of treatment satisfaction (\>24) on the Client Satisfaction Questionnaire (CSQ-8). The primary outcome will be a composite defined as meeting 3 out of 4 metrics listed here.
Time frame: 1 month after treatment
Acceptability as measured by percentage of individuals who complete an entire treatment course
Higher percentage of individuals who completed an entire course (i.e., 50 treatments) indicates higher acceptability. We hypothesize that 9/12 participants will complete at least 75% of treatments. The primary outcome will be a composite defined as meeting 3 out of 4 metrics here.
Time frame: 1 month after treatment
Safety as measured by reports of adverse events
We will monitor and report the rate of serious adverse events, including maternal seizures in the sample. We hypothesize that there will be no serious adverse events.
Time frame: 1 month after treatment
Feasibility as measured by the number of individuals treated throughout the study
Report of the number of individuals who received treatment throughout the entire study (i.e., approximately 2 years). We hypothesize that we will be able to enroll and treat 12 participants in two years. The primary outcome will be a composite defined as meeting 3 out of 4 metrics here.
Time frame: From the beginning to the end of the study
Montgomery-Åsberg Depression Rating Scale (MADRS)
A clinician rated tool used to assess the severity of depression in adults. The MADRS consists of 10 items, each scored on a 7 point scale 0-6 with higher scores indicating more severe depressive symptoms.
Time frame: From baseline to 1 month post treatment.
Assess the effects of accelerated TMS on birth outcomes and lactation
We will monitor and report neonatal APGAR scores from infants delivered from mothers in the sample, birth weights, intradelivery maternal pain scores, birth modality (e.g. vaginal or C-section), and maternal blood loss. For individuals postpartum, we will ask participants to log their milk supply daily during treatment to determine any effects
Time frame: Throughout the 5 days of treatment to 1 month post treatment
Beck Depression Inventory (BDI)
Depression severity rating scales (0-63, higher numbers indicate higher severity)
Time frame: Before treatment, daily throughout treatment, 2 week post treatment, and 1 month post treatment
Beck Anxiety Inventory (BAI)
Anxiety severity rating scale (0-63, higher numbers indicate higher severity)
Time frame: Before treatment, daily throughout treatment, 2 week post treatment, and 1 month post treatment
Young Mania Rating Scale (YMRS)
11 item scale evaluating mania. Scored 0-60. Higher score indicates worse outcome/higher mania
Time frame: Before treatment, daily throughout treatment, 2 week post treatment, and 1 month post treatment
Edinburgh Postnatal Depression Scale
A scale created to help identify women who may be suffering from postpartum depression. Each question is scored 0-3, with a maximum score of 30. A score of more than 10 suggests minor or major depression may be present.
Time frame: Before treatment, 2 weeks after treatment, and 1 month after treatment.
Hamilton Rating Scale for Depression
Designed to rate the severity of depression in individuals. Scores range from 0-52, a higher score indicating more severe depression.
Time frame: Before treatment, 2 weeks after treatment, and 1 month after treatment.
Plan to share: Undecided
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