Anxiety & Depression Association of America

Accelerated iTBS for Post Partum Depression

Purpose

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.

Condition

Post Partum Depression

Eligibility

Eligible Ages: Between 18 Years and 50 Years
Eligible Genders: Female
Accepts Healthy Volunteers: No

Inclusion Criteria

Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments. 2. Participants must be over the age of 18. 3. Participants must meet criteria for post-partum depression: a) onset of symptoms in the first year postpartum 4. Participants must have a HRSD17 greater than or equal to 14 at baseline.

Exclusion Criteria

Participants must not be pregnant. 2. Participants must not meet moderate or severe use disorder of any substance with the exception of Tobacco Use Disorder. 3. Participants must not have current psychotic symptoms. 4. Participants must not have a history of dementia or other cognitive impairment. 5. Participants must not have active suicidal ideation requiring hospitalization or a suicide attempt within the past 3 months. 6. Participants must not have any contraindications to receiving rTMS (e.g. metal implanted above the neck, history of seizure, any known brain lesion). 7. Participants must not have any unstable general medical conditions. 8. Participants must not have had eclampsia during pregnancy.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label pilot
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental iTBS	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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Medical University of South Carolina

Study Contact

Lisa McTeague, PhD
843-792-8274
mcteague@musc.edu

Detailed Description

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.