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Transcranial Magnetic Stimulation
Accelerated iTBS for Postpartum Depression
N/A
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must meet criteria for post-partum depression: a) onset of symptoms in the first four weeks postpartum OR b) depressive symptoms starting in the third trimester and worsening postpartum.
Participants must be over the age of 18.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
Study Summary
This trial is testing a new, more intense form of transcranial magnetic stimulation (TMS) to treat post-partum depression. TMS uses magnetic fields to stimulate nerve cells in the brain and is a non-invasive, safe treatment option.
Who is the study for?
This trial is for women over 18 with postpartum depression, which started during the last trimester or within four weeks after giving birth. They must have a certain level of depression severity and be able to consent. Women can't join if they're pregnant, have substance use disorders (except tobacco), had pre-eclampsia/eclampsia, contraindications to rTMS like metal in the head or seizures, unstable medical conditions, recent suicidal behavior, psychosis, or cognitive impairments.Check my eligibility
What is being tested?
The study tests an accelerated form of transcranial magnetic stimulation called iTBS on the left dorsolateral prefrontal cortex. It's given 10 times per day for six days to see if it's feasible and tolerable as a treatment for postpartum depression and how well it reduces depressive symptoms.See study design
What are the potential side effects?
While not specified here, iTBS side effects may include discomfort at the stimulation site, headache, lightheadedness or dizziness. Rarely there could be risks of seizure or hearing issues due to loud clicks during treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My depression started in the third trimester or within four weeks after giving birth.
Select...
I am over 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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).
Secondary outcome measures
Anti-depressant effect
Trial Design
1Treatment groups
Experimental Treatment
Group I: iTBSExperimental Treatment1 Intervention
accelerated iTBS to Left DLPFC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
iTBS
2019
Completed Phase 3
~640
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,605 Total Patients Enrolled
2 Trials studying Postpartum Depression
9,449 Patients Enrolled for Postpartum Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My depression started in the third trimester or within four weeks after giving birth.You do not have a history of memory or thinking problems.I do not have any unstable health conditions.I am over 18 years old.You should not be experiencing any symptoms of a mental illness called psychosis.You cannot have thoughts of hurting yourself that require hospitalization or have attempted suicide within the last 3 months.I don't have metal implants above the neck, a history of seizures, or known brain lesions.I can understand and agree to the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: iTBS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrolment limit for this clinical trial?
"Yes, current information from clinicaltrials.gov implies that this trial is actively seeking participants. It was published on the 24th of January 2018 and has been updated as recently as October 5th 2022. 10 volunteers will be recruited at 1 location for this experiment."
Answered by AI
What criteria must be met for an individual to qualify as a participant in this clinical trial?
"To be eligible participants in this investigation, individuals with postpartum depression must fall between the ages of 18 and 50. A maximum of 10 people will be accepted into this clinical trial."
Answered by AI
Are there any openings available to prospective participants in this trial?
"The details on clinicaltrials.gov verify that this trial is actively enrolling volunteers, having been first posted in January 24th 2018 and most recently updated October 5th 2022."
Answered by AI
Is there an age cutoff for inclusion in the trial?
"This particular medical trial has clear age boundaries, with only those 18-50 being eligible. Conversely, there are 197 trials aimed at participants under the age of 18 and 970 for seniors over 65 years old."
Answered by AI
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