Accelerated iTBS for Post Partum Depression
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 Start (Actual) 24 January 2018
🗓️ Primary Completion (Estimated) 31 May 2024
✅ Study Completion (Estimated) 31 July 2024
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Charleston, South Carolina, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 50 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 January 2018
  • First Submitted that Met QC Criteria 30 January 2018
  • First Posted 31 January 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 May 2024
  • Last Update Posted 28 May 2024
  • Last Verified May 2024