Accelerated theta burst treatment for postpartum depression
An Open Label Study to Assess the Feasibility and Tolerability of Accelerated Theta Burst Repetitive Transcranial Magnetic Stimulation (iTBS-rTMS) for the Treatment of Post-Partum Depression
NA · Medical University of South Carolina · NCT03417960
This study is testing a new treatment using brain stimulation for women with postpartum depression to see if shorter sessions can help them feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Medical University of South Carolina (other) |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT03417960 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and tolerability of intermittent theta burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex for women suffering from postpartum depression. Participants will undergo either 10 sessions per day over 6 days or 12 sessions per day over 5 days to assess the antidepressant effects of these treatment schedules. The goal is to determine if a shorter treatment duration is more acceptable and effective for this population compared to traditional longer protocols. The study aims to gather data that could inform larger future trials.
Who should consider this trial
Good fit: Ideal candidates are women over 18 who have been diagnosed with postpartum depression within the first year after childbirth.
Not a fit: Patients who are currently pregnant, have severe substance use disorders, or exhibit active psychotic symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a rapid and effective intervention for women experiencing postpartum depression.
How similar studies have performed: While transcranial magnetic stimulation has been shown to effectively treat depression, this specific approach using accelerated iTBS is novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)
Study contacts
- Study coordinator: Lisa McTeague, PhD
- Email: mcteague@musc.edu
- Phone: 843-792-8274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post Partum Depression, post partum depression, theta burst, transcranial magnetic stimulation