Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
FEMALE
NCT06968390

Accelerated TMS for Perinatal Depression

Led by Brigham and Women's Hospital · Updated on 2025-09-09

24

Participants Needed

1

Research Sites

73 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Accelerated TMS for Perinatal Depression

Who Can Participate

Age: 18Years - 55Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-55
  • Pregnant individuals must be between 14 and 34 weeks gestation at the time of treatment
  • Postpartum individuals must be within one year of delivery at the time of treatment
  • Patients will not be scanned after 32 weeks gestational age; scalp-based target localization offered beyond this
  • English proficiency sufficient for informed consent, questionnaires, and treatment
  • Primary diagnosis of major depressive disorder per DSM-V with MADRS score >20 and moderate to severe treatment resistance
  • Stable antidepressant medication regimen or medication free for 4 weeks prior to treatment and throughout treatment
  • Primary clinician responsible for psychiatric care and an obstetric provider responsible for obstetric care during the trial
  • Agreement to maintain usual caffeine or xanthine intake during treatment
Not Eligible

You will not qualify if you...

  • Concurrent use of rapid acting antidepressants (ketamine, esketamine) or electroconvulsive therapy
  • Receiving or planning other TMS treatments during participation
  • Obstetric concerns such as preeclampsia or frequent painful contractions (more than once every 10 minutes)
  • History of neurosurgical intervention for depression, autism spectrum disorder, intellectual disability, severe cognitive impairment, significant neurological illness, untreated endocrine disorder, or use of investigational drugs during study
  • Change of 30% or more in MADRS score between screening and baseline
  • Presence of mania, hypomania, psychosis, active suicidal ideation with plan or recent suicide attempt within 3 months
  • Neurological lesion or contraindications to TMS or MRI (e.g., metallic implants, severe insomnia requiring hypnotics)
  • Moderate or severe substance use disorder or signs of acute withdrawal
  • Existing tinnitus causing functional impairment
  • History of retinal detachment or other retinal pathology
  • Severe borderline personality disorder
  • Any other condition deemed by the principal investigator to interfere with the study or increase risk to the participant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

I

Interventional Psychiatry Research Group

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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Accelerated TMS for Perinatal Depression | DecenTrialz