Accelerated iTBS for Post Partum Depression

NCT03417960 | Recruiting DMC FDA Device

• 1 other identifier: Pro00073886
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

post partum depression; theta burst; transcranial magnetic stimulation

Outcome Measures

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).

  7 days

Secondary Outcomes (1)

• Anti-depressant effect

  4 weeks

Study Arms (1)

iTBS

EXPERIMENTAL

accelerated iTBS to Left DLPFC

Device: iTBS

Interventions

iTBS DEVICE

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.

iTBS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Participants must not have active suicidal ideation requiring hospitalization or a suicide attempt within the past 3 months.
• Participants must not have any contraindications to receiving rTMS (e.g. metal implanted above the neck, history of seizure, any known brain lesion).
• Participants must not have any unstable general medical conditions.
• Participants must not have had eclampsia during pregnancy.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Lisa McTeague, PhD

CONTACT

843-792-8274; mcteague@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Open label pilot

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: January 31, 2018
• Study Start: January 24, 2018
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)