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New treatment option for Perinatal Depression
Official title Accelerated TMS for Perinatal Depression
ClinicalTrials.gov ID: NCT06968390
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55, women only
You may be able to join if
- 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...
- Patients will not be scanned after 32 weeks gestational age due to the time needed to construct the individualized treatment target. Individuals...
- 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...
You likely can't join if
- 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...
- ≥ 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...
See the full eligibility 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...
- 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...
- 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)...
- 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...
- 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
- 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...
- ≥ 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.