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

Trial Summary

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 data supports the effectiveness of the treatment Intermittent Theta Burst Stimulation (iTBS) for postpartum depression?

Repetitive transcranial magnetic stimulation (rTMS), a similar treatment to iTBS, is FDA approved for major depression and may be useful for postpartum depression. It is known for its rapid effect, good tolerance, and safety for both the mother and baby. ^{1 2 3 4 5}

Is accelerated iTBS safe for humans?

Research shows that intermittent theta burst stimulation (iTBS) is generally safe and well-tolerated in humans, with studies reporting no adverse events in patients with bipolar depression and treatment-resistant depression. Some participants in a study with prolonged iTBS experienced tolerability issues, but overall, the treatment is considered safe. ^{6 7 8 9 10}

How is the treatment iTBS different from other treatments for postpartum depression?

iTBS (Intermittent Theta Burst Stimulation) is a non-invasive brain stimulation technique that uses magnetic fields to stimulate nerve cells in the brain, offering a rapid treatment option without the need for medication, which is beneficial for breastfeeding mothers. Unlike traditional drug treatments, it does not involve systemic effects or exposure to medications for the mother or infant. ^{1 3 5 11 12}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Interpersonal psychotherapy adapted for the group setting in the treatment of postpartum depression. [2018]

2. Scotland pubmed.ncbi.nlm.nih.gov

Effectiveness of the third wave cognitive behavior therapy for peripartum depression treatment-A systematic review. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation for the treatment of postpartum depression. [2021]

4. China pubmed.ncbi.nlm.nih.gov

[Effect of transcutaneous electrical acupoint stimulation combined with epidural labor analgesia on postpartum depression]. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Resting-state functional connectivity, cortical GABA, and neuroactive steroids in peripartum and peripartum depressed women: a functional magnetic resonance imaging and spectroscopy study. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Accelerated Intermittent Theta Burst Stimulation for Suicide Risk in Therapy-Resistant Depressed Patients: A Randomized, Sham-Controlled Trial. [2020]

7. France pubmed.ncbi.nlm.nih.gov

Twice-daily neuronavigated intermittent theta burst stimulation for bipolar depression: A Randomized Sham-Controlled Pilot Study. [2020]

8. United States 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. [2022]

9. England 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. [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

Prolonged intermittent theta burst stimulation in the treatment of major depressive disorder: a case series. [2022]

11. Australia pubmed.ncbi.nlm.nih.gov

The preventive effect of internet-based cognitive behavioral therapy for prevention of depression during pregnancy and in the postpartum period (iPDP): a large scale randomized controlled trial. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Neurosteroids and Postpartum Depression: The Mechanism, Efficacy, and Approval of Brexanolone and Zurzuvae. [2023]