What side effects are associated with this type of intervention?

Common treatments for postpartum depression include antidepressant medications, psychotherapy, and neuromodulation techniques such as transcranial magnetic stimulation (TMS). Specifically, for treatments similar to Intermittent Theta Burst Stimulation (iTBS), side effects may include mild headaches, scalp discomfort at the stimulation site, and transient lightheadedness. These side effects are generally well-tolerated and temporary. It is important for patients to discuss potential side effects and treatment options with their healthcare provider to determine the best course of action.

What prior FDA approvals exist?

The FDA has approved brexanolone (Zulresso) for the treatment of postpartum depression, which is administered as a continuous intravenous infusion over 60 hours. While there are no specific FDA approvals for treatments exactly like intermittent theta burst transcranial magnetic stimulation (iTBS) for postpartum depression, transcranial magnetic stimulation (TMS) in general has been explored for various types of depression, including postpartum depression. TMS involves non-invasive brain stimulation and has shown promise in clinical studies for its antidepressant effects.

What other types of research exist?

Promising, novel alternatives to iTBS for postpartum depression include: 1) Vagus Nerve Stimulation (VNS), which has shown long-term efficacy in treatment-resistant depression. 2) Transcranial Direct Current Stimulation (tDCS), which has been explored for improving symptoms in various neuropsychiatric conditions. 3) Deep Brain Stimulation (DBS), particularly targeting areas like the subcallosal cingulate, which has shown benefits in treatment-resistant depression. These alternatives offer different mechanisms of action and may provide additional options for patients and clinicians.

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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.

Must not have

Participants must not have any unstable general medical conditions.

Participants must not have any contraindications to receiving rTMS (e.g. metal implanted above the neck, history of seizure, any known brain lesion).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new magnetic pulse therapy for women with post-partum depression. The therapy aims to improve mood by stimulating a specific brain area. Researchers are comparing two different treatment schedules to see which is more effective and easier for patients to complete. This therapy has been used for major depression and postpartum depression.

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.

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.

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 below

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My depression started in the third trimester or within four weeks after giving birth.

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any unstable health conditions.

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I don't have metal implants above the neck, a history of seizures, or known brain lesions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Anti-depressant effect

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Intermittent Theta Burst Transcranial Magnetic Stimulation (iTBS) targets the left dorsolateral prefrontal cortex (DLPFC) to modulate neural activity. This area of the brain is associated with mood regulation and cognitive functions. By delivering rapid bursts of magnetic pulses, iTBS aims to enhance excitatory neurotransmission, potentially correcting the neural imbalances seen in Postpartum Depression (PPD). This non-invasive treatment is particularly relevant for PPD patients as it offers a rapid, drug-free alternative that can be crucial for new mothers who may be breastfeeding and wish to avoid pharmacological interventions. Other common treatments for PPD include antidepressants, psychotherapy, and hormonal therapies, each working through different mechanisms such as altering neurotransmitter levels, providing emotional support, or stabilizing hormonal fluctuations.