RECRUITING

Accelerated TMS for Perinatal Depression

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Conditions

Perinatal DepressionPost Partum DepressionMajor Depressive DisorderTMSAccelerated TMSPerinatalPostpartumPostpartum DepressionPregnant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Perinatal Accelerated iTBS Neuromodulation Therapy

Quick Facts

Study Start:2025-08-05
Study Completion:2027-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06968390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-55
  2. * 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.
  3. * 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.
  4. * English proficiency sufficient for informed consent, questionnaires/tasks, and treatment
  5. * 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)
  6. * 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.
  7. * 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.
  8. * Agreement to lifestyle considerations: Continue usual intake patterns of caffeine- or xanthine-containing products (e.g. coffee, tea, soft drinks, chocolate) throughout treatment
  1. * Concurrent use of rapid acting antidepressant agent (ketamine/esketamine/ECT)
  2. * Receiving or planning to receive other TMS treatments during course of participation
  3. * Obstetric concerns: Preeclampsia and/or current frequent, painful contractions (more than one every 10 minutes)
  4. * 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
  5. * ≥ 30% change in MADRS score between screening and baseline
  6. * 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
  7. * Existing tinnitus (ringing in the ears) that causes functional impairment
  8. * History of retinal detachment or other retinal pathology
  9. * Severe borderline personality disorder
  10. * Any other condition deemed by the PI to interfere with the study or increase risk to the participant

Contacts and Locations

Study Contact

Interventional Psychiatry Research Group
CONTACT
617 525 3536
mgbpaint@mgb.org

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-05
Study Completion Date2027-01-01

Study Record Updates

Study Start Date2025-08-05
Study Completion Date2027-01-01

Terms related to this study

Keywords Provided by Researchers

  • TMS
  • Accelerated TMS
  • Perinatal Depression
  • Perinatal
  • Postpartum
  • Postpartum Depression
  • Major Depressive Disorder
  • Pregnant

Additional Relevant MeSH Terms

  • Perinatal Depression
  • Post Partum Depression
  • Major Depressive Disorder