Recruiting

iTBS

Sponsor:

Medical University of South Carolina

Code:

NCT03417960

Conditions

Post Partum Depression

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

iTBS

Study Details

Brief summary:

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.

Conditions

Post Partum Depression

Study ID

NCT03417960

Start date

Jan 24, 2018

Status verified date

May, 2026

Completion date

Aug 30, 2027

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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:

1. 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

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: iTBS

accelerated iTBS to Left DLPFC

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Lisa McTeague, PhD

843-792-8274mcteague@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Lisa McTeague, PhD

843-792-8274mcteague@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • post partum depression
  • theta burst
  • transcranial magnetic stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-05-22.