Accelerated TMS for perinatal and postpartum depression
Perinatal Accelerated iTBS Neuromodulation Therapy
This project will test whether an accelerated course of TMS (multiple sessions per day over five days) can help pregnant and postpartum people with major depressive disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06968390 on ClinicalTrials.gov |
What this trial studies
This single-site interventional study delivers an accelerated Transcranial Magnetic Stimulation (TMS) protocol consisting of multiple daily sessions over five days to pregnant and postpartum individuals with major depressive disorder. Participants generally must be 18–55 years old and between 14–34 weeks gestation or within one year after delivery; MRI-based individualized targeting is used when scanning is possible (not after 32 weeks), with scalp-based targeting offered if needed. The study focuses on rapid treatment response, safety, and tolerability of the accelerated protocol in the perinatal population, with clinical ratings collected before, during, and after the treatment course. Treatments are provided in person at the study site and participants must be able to attend the intensive five-day schedule.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18–55 with a DSM-V diagnosis of major depressive disorder who are between 14–34 weeks pregnant or within one year after delivery and who can attend the intensive five-day, in-person treatment schedule.
Not a fit: People with standard contraindications to TMS (for example, certain implanted metal or a history of uncontrolled seizures), those beyond the allowed gestational window (notably near or past 36 weeks), or those unable to complete the intensive in-person visits are less likely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could provide faster, non-drug relief from depression during pregnancy or the postpartum period, potentially reducing risks to both parent and baby.
How similar studies have performed: Previous work, including open-label accelerated iTBS protocols such as SAINT, has shown rapid and robust antidepressant effects in small samples and conventional TMS has shown promise in perinatal depression, though larger controlled data are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-55 * All individuals must be 14-34 weeks gestational age or within one year of delivery at the time of treatment. The odds of delivery nears 10% after 36 weeks, which would limit participants from being able to complete the study and interfere with the primary study aim to understand safety and tolerability. Additionally, after 36 weeks, the standard of care is weekly obstetric check-in visits, which would be challenging for patients to complete given the time demands of the study protocol. * Patients will not be scanned after 32 weeks gestational age due to the time needed to construct the individualized treatment target. Individuals seeking treatment beyond 32 weeks will be offered scalp-based target localization so as not to limit patient access to care. * English proficiency sufficient for informed consent, questionnaires/tasks, and treatment * Primary diagnosis of major depressive disorder per DSM-V criteria (MINI International Neuropsychiatric Interview/ Structured Clinical Interview for DSM-5): \>20 on the Montgomery-Åsberg Depression Rating Scale (MADRS) and moderate to severe level of treatment resistance (Maudsley Staging Method) * Stable antidepressant medication regimen, or remain medication free, for 4 weeks prior to treatment and to remain on this regimen throughout the treatment course. We request that this regimen remain stable until the 1 month post-treatment if clinically appropriate. * Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial in addition to an obstetric provider responsible for obstetric care. * Agreement to lifestyle considerations: Continue usual intake patterns of caffeine- or xanthine-containing products (e.g. coffee, tea, soft drinks, chocolate) throughout treatment Exclusion Criteria: * Concurrent use of rapid acting antidepressant agent (ketamine/esketamine/ECT) * Receiving or planning to receive other TMS treatments during course of participation * Obstetric concerns: Preeclampsia and/or current frequent, painful contractions (more than one every 10 minutes) * History of: Neurosurgical intervention for depression, autism spectrum disorder, intellectual disability, severe cognitive impairment, significant neurological illness (e.g., dementia, Parkinson's, Huntington's, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, brain lesion), untreated or insufficiently treated endocrine disorder, and/or treatment with investigational drug or intervention during the study period * ≥ 30% change in MADRS score between screening and baseline * Anyone presenting with: Mania or hypomania, psychosis, active suicidal ideation with plan and some intent to act or a suicide attempt (defined by C-SSRS) within the past 3 months, neurological lesion, contraindications to either TMS or MRI (e.g., metallic implants, severe insomnia \> 4 hours per night with hypnotic, etc.), and/or current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal * Existing tinnitus (ringing in the ears) that causes functional impairment * History of retinal detachment or other retinal pathology * Severe borderline personality disorder * Any other condition deemed by the PI to interfere with the study or increase risk to the participant
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Interventional Psychiatry Research Group
- Email: mgbpaint@mgb.org
- Phone: 617 525 3536
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.