Actively Recruiting
An Open Label Study to Assess the Feasibility and Tolerability of Accelerated Theta Burst Repetitive Transcranial Magnetic Stimulation (iTBS-rTMS) for the Treatment of Post-Partum Depression
Led by Medical University of South Carolina · Updated on 2026-05-22
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and tolerability of an accelerated intermittent theta burst stimulation (iTBS) treatment targeting the left dorsolateral prefrontal cortex in women with post-partum depression. This open-label study aims to explore a shorter treatment protocol compared to the standard six-week FDA-approved TMS treatment, which may be difficult for many women with post-partum depression to complete. The study also seeks to characterize the potential anti-depressant effects of this new treatment schedule to inform future larger trials. The study includes two parts with different treatment schedules. In the first part, participants receive 10 iTBS sessions per day over six days, divided into two weeks with a treatment-free week in between. In the second part, participants undergo 12 iTBS sessions per day over five consecutive days. Treatment is delivered at 120% of the resting motor threshold using a MagVenture MagPro100 device and Cool-B65 coil, targeting the left dorsolateral prefrontal cortex using the Beam-F3 method. During the study, women with post-partum depression are closely monitored for feasibility by assessing retention rates and tolerability by measuring the ability to receive the full treatment dose. Effectiveness is evaluated using depression rating scales over four weeks. Participants will complete assessments and treatment sessions over the specified treatment days, and safety measures include screening for contraindications and monitoring for adverse effects. The total study duration and follow-up periods are designed to capture both the immediate and short-term impact of the treatment.
CONDITIONS
Brief Title
Accelerated iTBS for Post Partum Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be able to provide informed consent and function at an intellectual level sufficient to complete all assessments.
- Participants must be over 18 years old.
- Participants must meet criteria for post-partum depression with symptom onset within the first year postpartum.
- Participants must have a Hamilton Rating Scale for Depression (HRSD17) score of 14 or higher at baseline.
You will not qualify if you...
- Participants must not be pregnant.
- Participants must not have moderate or severe substance use disorder, except tobacco use disorder.
- Participants must not have current psychotic symptoms.
- Participants must not have a history of dementia or other cognitive impairment.
- Participants must not have active suicidal ideation requiring hospitalization or a suicide attempt within the past 3 months.
- Participants must not have contraindications to receiving rTMS (e.g., metal implanted above the neck, history of seizures, brain lesions).
- Participants must not have unstable general medical conditions.
- Participants must not have had eclampsia during pregnancy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks depending on study part
Participants receive accelerated intermittent theta burst stimulation (iTBS) to treat post-partum depression. The treatment consists of multiple sessions delivered over a short period to assess feasibility and tolerability.
Up to 6 treatment days in Study 1 or 5 treatment days in Study 2 with multiple sessions per day
Duration - 4 weeks
Participants are monitored for anti-depressant effects and tolerability following the treatment phase.
Visits scheduled during the 4-week follow-up period to assess outcomes
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
L
Lisa McTeague, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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