An interventional study of iTBS in Post Partum Depression, sponsored by Medical University of South Carolina. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
Study 1: The investigators are studying the feasibility and tolerability of 10x/day intermittent theta burst (excitatory) transcranial magnetic stimulation to the left dorsolateral prefrontal cortex over the course of 6 days for women with post-partum depression. The investigators further aim to characterize the anticipated anti-depressant effect of this treatment paradigm.
Study 2: The investigators are studying the feasibility and tolerability of 12 sessions/day of intermittent theta burse (excitatory) transcranial magnetic stimulation to the left dorsolateral prefrontal cortex over 5 days for women with post-partum depression. The investigators aim to compare the two different treatment schedules.
Study 1: This is an open-label study designed to investigate the feasibility and tolerability of a novel TMS treatment protocol to treat depression in women with post-partum depression. It is known that TMS can effectively treat depression. The FDA approved protocol lasts 6 weeks and is not feasible for many women with post-partum depression. The investigators are investigating a 6 day treatment for depression which may be more acceptable for this population. The investigators further aim to characterize the ant-depressant effect of this protocol in order to design a larger trial.
Study 2: In part 2 of this study, the treatment schedule is 12 sessions over 5 days that can be completed with 8. All other procedures, inclusion/exclusion criteria, and number of total pulses delivered is the same as study 1.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 40 is below the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
accelerated iTBS to Left DLPFC
Device: iTBS
The investigators will treat post-partum depressed subjects with accelerated intermittent theta burst stimulation. iTBS will be delivered via a MagVenture MagPro100 and Cool-B65 coil. The investigators will use a standard resting motor threshold (rMT) determination to determine the TMS dose. Treatment will be delivered at 120% of the motor threshold. In study 1, the accelerated paradigm will consist of 10 such sessions separated by 15 minutes, for three treatment days per week. There will be 2 weeks of 10 sessions on each of three days for a total of six treatment days, divided by one treatment-free week between treatment weeks. In study 2, the accelerated paradigm will consist of 12 sessions per day for 5 total treatment days. Treatments will be delivered at the 10-20 EEG coordinate for F3 (approximating the left DLPFC), and will be found using the Beam-F3 method.
Determine feasibility and tolerability of accelerated iTBS for postpartum depression. The investigators hope to retain >80% of recruited patients (feasibility) and reach a full treatment dose of 120%rMT in >80% of enrolled women (tolerability).
Determine feasibility and tolerability of accelerated iTBS for postpartum depression. The investigators hope to retain \>80% of recruited patients (feasibility) and reach a full treatment dose of 120%rMT in \>80% of enrolled women (tolerability).
Time frame: 7 days
Anti-depressant effect
Determine the preliminary anti-depressant effect size of a course of accelerated iTBS for women with postpartum depression. We hypothesize that at least 30% of post-partum depressed subjects receiving accelerated iTBS will achieve a response (50% reduction in symptoms as measured on Ham-D) at 4 weeks.
Time frame: 4 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2018 (actual). Primary completion is estimated for Aug 2027, 115 months after the start.
Of 256 non-industry interventional studies with no phase under Depression, Postpartum, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 36. This study's planned 115 months is above that.
Counting every sponsor, half of 262 studies reached it within 23 months; a quarter within 11 and three quarters within 36.
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Medical University of South Carolina →