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Accelerated iTBS for Post Partum 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Study 2: In part 2 of this study, the treatment schedule is 12 sessions over 5 days that can be completed with 8."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests magnetic pulses to a brain area in women with depression that began in the first year after childbirth. It compares 10 sessions a day for 6 days with 12 sessions a day for 5 days. Researchers want to learn how well women can complete and handle the treatment and whether it helps 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Can understand and agree to join the study and can complete its tests accurately.
  • Are older than 18.
  • Have depression symptoms that began in the first year after childbirth.
  • Score at least 14 on the HRSD17 depression rating scale at the start of the study.

Who can't join

  • Are pregnant.
  • Have a moderate or severe substance use disorder, except tobacco use disorder.
  • Currently have symptoms of psychosis, such as seeing or hearing things that are not there.
  • Have a history of dementia or other problems with memory or thinking.
  • Have thoughts of suicide that require a hospital stay, or attempted suicide in the past 3 months.
  • Have a condition that makes magnetic brain treatment unsafe, such as metal implanted above the neck, past seizures, or a known area of brain damage.
  • Have a medical condition that is not stable.
  • Had eclampsia, a condition involving seizures, during pregnancy.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

SC