Accelerated iTBS for Postpartum Depression

Overseen By Lisa McTeague, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Pregnancy, Substance use disorder, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 6 days

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for treating postpartum depression using intermittent theta burst stimulation (iTBS). Researchers aim to determine if this method, which uses magnetic pulses to stimulate a specific brain area, is both feasible and effective in reducing depression symptoms. They are also comparing two different treatment schedules to identify the more effective one. Women who have experienced postpartum depression within the first year after giving birth and have significant symptoms might be suitable candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for postpartum depression.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this iTBS technique is safe for postpartum depression?

Research has shown that iTBS (a type of brain stimulation) is generally safe and well-tolerated. One study demonstrated that using iTBS on a specific brain area quickly and safely reduced depression symptoms. Another study with teenagers found that iTBS sessions over ten days were both effective and safe. Importantly, these studies reported no serious side effects, supporting the safety of iTBS. This indicates that any side effects were neither significant nor harmful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for postpartum depression, which often involve antidepressants or psychotherapy, accelerated iTBS (intermittent Theta Burst Stimulation) is a non-invasive brain stimulation technique that targets the left dorsolateral prefrontal cortex (DLPFC). This method is unique because it has the potential to produce faster results, often within days, compared to the weeks it typically takes for medication to show effects. Researchers are excited about iTBS because it offers a treatment option that could be particularly beneficial for new mothers who need quick relief from depressive symptoms without the side effects associated with medications.

What evidence suggests that iTBS is effective for postpartum depression?

Research has shown that intermittent theta-burst stimulation (iTBS) can effectively reduce symptoms of depression. In one study, 69.1% of patients responded well to iTBS, and 53.7% experienced complete relief from their symptoms. Another study found that just two days of iTBS treatment led to quick improvements in depression symptoms, with significant effects lasting for weeks. This evidence suggests that iTBS, currently being tested in this trial, could be a promising option for treating postpartum depression. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Participants must have a HRSD17 >13 at baseline.

I am over 18 years old.

Exclusion Criteria

Participants must not meet moderate or severe use disorder of any substance with the exception of Tobacco Use Disorder.

Participants must not have had pre-eclampsia or eclampsia during pregnancy.

You do not have a history of memory or thinking problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive accelerated iTBS to the left dorsolateral prefrontal cortex for 6 days (Study 1) or 5 days (Study 2)

6 days

10 sessions/day (Study 1) or 12 sessions/day (Study 2)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• iTBS

Trial Overview 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.

How Is the Trial Designed?

Group I: iTBS Experimental Treatment 1 Intervention

accelerated iTBS to Left DLPFC

iTBS is already approved in United States for the following indications:

Approved in United States as iTBS for:

• Treatment-resistant depression
• Major depressive disorder

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

In a study involving 208 participants with treatment-resistant depression, both twice-daily and once-daily intermittent theta burst stimulation (iTBS) protocols showed improvements in depression scores, but there was no significant difference in efficacy between the two schedules after 10 and 30 days.

Response and remission rates were low in both treatment groups, indicating that neither protocol significantly accelerated the improvement of depressive symptoms in patients with treatment-resistant depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized sham controlled comparison of once vs twice-daily intermittent theta burst stimulation in depression: A Canadian rTMS treatment and biomarker network in depression (CARTBIND) study. Blumberger, DM., Vila-Rodriguez, F., Wang, W., et al.[2022]

In a study of 26 patients with bipolar depression, active intermittent theta burst stimulation (iTBS) showed a high response rate of 72% and a remission rate of 42%, indicating its potential efficacy in treating this condition.

No adverse events were reported, demonstrating that iTBS is safe and well-tolerated, but further research with larger sample sizes is needed to confirm its superiority over sham treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twice-daily neuronavigated intermittent theta burst stimulation for bipolar depression: A Randomized Sham-Controlled Pilot Study. Bulteau, S., Beynel, L., Marendaz, C., et al.[2020]

Intermittent theta burst stimulation (iTBS) is as effective as standard high-frequency (10 Hz) rTMS for treating treatment-resistant depression, showing non-inferiority in improving depression scores over 4-6 weeks in a study with 414 participants.

Both iTBS and 10 Hz rTMS had similar safety profiles and dropout rates, with headaches being the most common side effect, indicating that iTBS can be a viable alternative that allows for more patients to be treated in a shorter time without losing effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Blumberger, DM., Vila-Rodriguez, F., Thorpe, KE., et al.[2022]

A group-based interpersonal psychotherapy (IPT) approach significantly reduced depression scores in 17 women diagnosed with postpartum depression, showing both immediate and lasting effects over a 6-month follow-up.

The study suggests that group IPT can be an effective treatment for postpartum depression, although limitations such as small sample size and lack of a control group may affect the reliability of the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interpersonal psychotherapy adapted for the group setting in the treatment of postpartum depression. Klier, CM., Muzik, M., Rosenblum, KL., et al.[2018]

Accelerated intermittent Theta Burst Stimulation (iTBS) was found to be safe and well tolerated in a study of 50 treatment-resistant depressed patients, with no worsening of suicidal ideation observed during the treatment.

The study showed a significant decrease in suicide risk, as measured by the Beck Scale of Suicide Ideation, lasting up to one month after treatment, regardless of whether patients received active or sham stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated Intermittent Theta Burst Stimulation for Suicide Risk in Therapy-Resistant Depressed Patients: A Randomized, Sham-Controlled Trial. Desmyter, S., Duprat, R., Baeken, C., et al.[2020]

In a study of 27 participants, a prolonged intermittent theta burst stimulation (piTBS) protocol using 1,800 pulses showed limited effectiveness for major depressive disorder, with only 18.2% of participants achieving a response and 9.1% reaching remission.

Safety and tolerability were concerns, as 18.5% of participants experienced issues, suggesting that while piTBS is a promising approach, further research is needed to optimize its parameters and improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged intermittent theta burst stimulation in the treatment of major depressive disorder: a case series. Richard, M., Noiseux, C., Desbeaumes Jodoin, V., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032725001521

Left prefrontal intermittent theta-burst stimulation therapy ... The response and remission rates among completers were 69.1 % and 53.7 %, respectively. •. Found no significant difference between 600- and 1200 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39761754/

Efficacy study of intermittent theta burst stimulation(iTBS) in ... The current study suggests that two days of active iTBS to the DLPFC region can rapidly, safely, and effectively improve depressive symptoms ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2830095

Accelerated Intermittent Theta-Burst Stimulation for ... Within-group improvements for active aiTBS indicated a significant and sustained reduction in depression severity at 1 and 4 weeks. Several ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06968390

NCT06968390 | Accelerated TMS for Perinatal Depression We are studying a treatment for depression called accelerated Transcranial Magnetic Stimulation (TMS) among pregnant and postpartum individuals.

5. nature.com nature.com/articles/s41591-023-02764-z

Connectivity-guided intermittent theta burst versus ... - Nature Persistent decreases in depressive symptoms were seen over 26 weeks, with no differences between arms on the primary outcome GRID Hamilton ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03417960

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 ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006322325013563

Efficacy and Safety of Accelerated Intermittent Theta-burst ... In this trial, a-iTBS, administered five sessions per day for ten days, is effective and safe for adolescents with non-treatment-resistant MDD.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07033780

NCT07033780 | Theta-Burst Stimulation to Treat Depression The goal of this clinical trial is to explore the effects of non-invasive brain stimulation protocols using intermittent theta-burst stimulation (iTBS) on ...