Accelerated iTBS for Post Partum Depression
ConditionPost Partum Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorMedical University of South Carolina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
Participants must be over the age of 18.
Participants must meet criteria for post-partum depression: a) onset of symptoms in the first year postpartum
Participants must have a HRSD17 greater than or equal to 14 at baseline.
Disqualifiers
Participants must not be pregnant.
Participants must not meet moderate or severe use disorder of any substance with the exception of Tobacco Use Disorder.
Participants must not have current psychotic symptoms.
Participants must not have a history of dementia or other cognitive impairment.
Trial design
Design model
Single group
Treatments tested in this trial
iTBS
DeviceThe 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: iTBSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 daysSecondary outcomes
1
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 weeksSponsors and contacts
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Source ClinicalTrials.gov