MST for Bipolar Disorder

Overseen By Edison Leung, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edison Leung

Must not be taking: Antiepileptics, Benzodiazepines, Lithium

Disqualifiers: Implanted devices, Substance use, Epilepsy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the effectiveness and safety of magnetic seizure therapy (MST) compared to electroconvulsive therapy (ECT) for treating bipolar depression and treatment-resistant depression. Researchers will divide participants into groups to receive either MST or ECT to evaluate which treatment works better and has fewer side effects. Suitable candidates include individuals experiencing severe depression despite trying at least two different antidepressant medications and having a history of mood swings, including episodes of high energy or mania. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatment options for depression.

Do I need to stop taking my current medications for the trial?

The trial requires you to be on a stable drug regimen of psychotropic medication for at least 6 weeks before starting. Some medications, like lithium, will be tapered off before the procedure. Antiepileptics and benzodiazepines are generally not allowed, but short or mid-acting benzodiazepines can be skipped 10 hours before procedures. Other medications with weak antiepileptic features will be reviewed and possibly adjusted by the study doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) can effectively treat mood disorders like bipolar depression. MST is generally well-tolerated, and studies suggest it may have fewer effects on memory and thinking compared to ECT. Participants in these studies often experienced improvement in depression symptoms with MST.

ECT is also effective and safe for severe bipolar disorder. It has significantly reduced symptoms and is generally well-tolerated with few side effects. Most patients respond well to ECT, with many experiencing major improvements.

Both treatments have demonstrated effectiveness for mood disorders, but MST might be gentler on memory and thinking skills. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about magnetic seizure therapy (MST) for bipolar disorder because it offers a potentially safer and less invasive alternative to electroconvulsive therapy (ECT), the current standard of care. MST uses magnetic pulses to induce seizures in the brain, which could lead to fewer cognitive side effects compared to the electrical currents used in ECT. This new approach could provide a more targeted treatment with a better side effect profile, making it a promising option for patients who are sensitive to the cognitive impacts of traditional therapies.

What evidence suggests that this trial's treatments could be effective for Bipolar Depression and Treatment Resistant Depression?

Research has shown that Magnetic Seizure Therapy (MST), a treatment under study in this trial, can greatly improve symptoms in people with bipolar depression that hasn't responded to other treatments, with minimal effects on thinking and memory. Participants in this trial may receive either MST or Electroconvulsive Therapy (ECT), another treatment option under study. Studies have found MST to be as effective as ECT in reducing major depression symptoms. MST often results in a high rate of improvement and causes fewer thinking and memory problems compared to ECT, making it a promising option for those with mood disorders like bipolar depression. ^{6 7 8 9 10}

Who Is on the Research Team?

Edison Leung, MD, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for adults aged 22-85 with Bipolar Depression or Treatment Resistant Depression who are in good health and not pregnant. Participants must be on a stable medication regimen for at least 6 weeks, able to consent, use effective contraception, and have no history of seizures or severe psychiatric conditions like psychosis.

Inclusion Criteria

For females of reproductive potential: use of highly effective contraception and agreement to use such a method during study participation and for an additional one week after the end of ECT/TMS administration

I am a man who can father children and will use contraception.

If you are a woman who can have children, you need to use a very effective form of birth control for at least 1 month before the study starts and continue using it during the study and for one week after it ends. Please note that while electroconvulsive therapy (ECT) is safe for pregnant women with depression, the effects of transcranial magnetic stimulation (TMS) on a fetus are still unknown.

Exclusion Criteria

Known allergic reactions to components of anaesthetic or induction agents

I do not have dementia or any illness that affects my brain function.

I have a history of epilepsy or seizures that doctors couldn't explain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either magnetic seizure therapy (MST) or electroconvulsive therapy (ECT) for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ECT
• MST

Trial Overview The study compares Magnetic Seizure Therapy (MST) with Electroconvulsive Therapy (ECT) to see which is more effective for treating Bipolar Depression and Treatment Resistant Depression. It also examines the side effects associated with each treatment method.

How Is the Trial Designed?

Group I: magnetic seizure therapy (MST) Experimental Treatment 1 Intervention

Group II: electroconvulsive therapy (ECT) Active Control 1 Intervention

ECT is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Electroconvulsive therapy for:

• Major depressive disorder
• Mania
• Autism
• Catatonia

Approved in United States as Electroconvulsive therapy for:

• Major depressive disorder
• Mania
• Autism
• Catatonia

Approved in Canada as Electroconvulsive therapy for:

• Major depressive disorder
• Mania
• Autism
• Catatonia

Who Is Running the Clinical Trial?

Edison Leung

Lead Sponsor

Trials

1

Recruited

60+

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

Magnetic seizure therapy (MST) can induce acute manic symptoms in patients with major depressive episodes, as demonstrated in two cases during an ongoing study of treatment-resistant depression.

Both patients experienced mania after several MST treatments, but their symptoms resolved quickly with medication after stopping the therapy, highlighting the need to monitor for mood changes as a potential side effect of MST.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic seizure therapy-induced mania: a report of 2 cases. Noda, Y., Daskalakis, ZJ., Fitzgerald, PB., et al.[2015]

Magnetic seizure therapy (MST) shows significant antidepressant effects in mood disorders, with remission rates between 30% and 40%, based on a review of 8 clinical studies.

MST appears to have a better cognitive safety profile compared to electroconvulsive therapy (ECT), with no significant cognitive side effects reported, making it a promising alternative for treating major depressive disorder and bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Seizure Therapy for Unipolar and Bipolar Depression: A Systematic Review. Cretaz, E., Brunoni, AR., Lafer, B.[2018]

Magnetic seizure therapy (MST) shows no clear differences in effectiveness compared to electroconvulsive therapy (ECT) for treating treatment-resistant depression (TRD), based on a systematic review of three studies involving 65 participants.

The evidence regarding MST's impact on cognitive function, quality of life, and dropout rates is also inconclusive, highlighting the need for larger and better-designed trials to assess its true efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic seizure therapy for treatment-resistant depression. Jiang, J., Zhang, C., Li, C., et al.[2022]

Magnetic seizure therapy (MST) is as effective as bifrontal electroconvulsive therapy (ECT) in treating depression, with response rates of 72.2% for MST compared to 81.5% for ECT, indicating it can be a viable alternative.

MST demonstrated significantly fewer cognitive side effects, showing improvements in immediate and delayed memory and attention, along with shorter recovery times for consciousness and orientation compared to ECT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shorter recovery times and better cognitive function-A comparative pilot study of magnetic seizure therapy and electroconvulsive therapy in patients with depressive episodes. Zhang, J., Ren, Y., Jiang, W., et al.[2023]

Magnetic seizure therapy (MST) successfully treated a case of treatment-resistant depression in a patient with bipolar I disorder, showing promise as an effective alternative to electroconvulsive therapy (ECT).

MST resulted in shorter seizure durations and less cognitive side effects compared to ECT, with the patient recovering to full orientation more quickly, suggesting MST may offer a safer profile for treating severe depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic seizure therapy of treatment-resistant depression in a patient with bipolar disorder. Kayser, S., Bewernick, B., Axmacher, N., et al.[2009]

Electroconvulsive therapy (ECT) is a safe and effective treatment for severe mental disorders when conducted with proper monitoring.

Common side effects of ECT include anterograde amnesia, post-ictal confusion, and physical discomforts like nausea and headaches, but these are generally manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RECURRENT SELF-LIMITED HYPERTHERMIA FOLLOWING ELECTROCONVULSIVE THERAPY. Sánchez-Morla, EM., Gómez de Las Heras, V.[2023]

Magnetic seizure therapy (MST) allows for significantly faster recovery times compared to electroconvulsive therapy (ECT), with patients opening their eyes about 3 minutes after MST versus 6.7 minutes after ECT, indicating a potential advantage in post-treatment recovery.

Both MST and ECT were found to have comparable levels of anaesthetic depth during treatment, but MST patients exhibited higher bispectral index (BIS) values post-seizure, suggesting better overall recovery and less sedation after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral bispectral index monitoring during and after electroconvulsive therapy compared with magnetic seizure therapy for treatment-resistant depression. Soehle, M., Kayser, S., Ellerkmann, RK., et al.[2018]

Electroconvulsive therapy (ECT) is being evaluated for safety in patients with depression and multiple sclerosis (MS), but concerns remain about potential neurological deterioration and complications.

A case study highlighted a significant risk, as a patient experienced a grand mal seizure after their 14th ECT treatment, raising questions about the safety of this intervention in MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroconvulsive therapy in patient with psychotic depression and multiple sclerosis. Urban-Kowalczyk, M., Rudecki, T., Wróblewski, D., et al.[2014]

Electroconvulsive therapy (ECT) carries several accidental risks, including skin burns and misdelivery of the electrical stimulus, which can affect treatment efficacy and patient safety.

Understanding and preventing these risks is crucial for improving the safety and effectiveness of ECT as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and ECT Stimulus Electrodes: II. Clinical Procedures. Swartz, CM.[2019]

In a study of 621 patients undergoing electroconvulsive therapy (ECT), 21.9% reported headaches and 9% reported myalgia 6 hours after treatment, indicating that headaches are a more common side effect than myalgia.

Headaches were generally mild and decreased in intensity and frequency within 6 hours post-ECT, while myalgia showed a decrease in frequency but not in intensity, suggesting that while side effects occur, they are often tolerable and transient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Incidence and Predictors of Headache and Myalgia in Patients After Electroconvulsive Therapy (ECT). Haghighi, M., Sedighinejad, A., Naderi Nabi, B., et al.[2020]

In a follow-up study of 70 patients with bipolar disorder who received electroconvulsive therapy (ECT), 93% maintained at least a partial therapeutic response for over 90% of the follow-up period, indicating ECT's long-term efficacy for treating severe depression and mixed states.

73% of patients achieved full remission after ECT, but those with mixed episodes and comorbid anxiety disorders experienced higher relapse rates, suggesting that these factors may negatively impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naturalistic follow-up in bipolar patients after successful electroconvulsive therapy. Medda, P., Barbuti, M., Novi, M., et al.[2021]

Electroconvulsive therapy (ECT) is generally a safe and effective treatment for psychiatric disorders, but it can lead to rare complications such as prolonged seizures, as demonstrated in a case involving an 83-year-old female patient.

In this case, the patient experienced a prolonged seizure lasting about 700 seconds during her third ECT session, highlighting the need for careful monitoring and the development of preventive protocols to manage such risks in future ECT treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epileptic status as a complication of electroconvulsive therapy: a case report. Reyes-Molón, L., Trebbau-López, H., Saiz-González, D.[2012]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7850154/

Magnetic seizure therapy is efficacious and well tolerated for ... In treatment-resistant bipolar depression, magnetic seizure therapy produced significant improvements in depression symptoms with minimal effects on cognitive ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04080778

Magnetic Seizure Therapy in Bipolar Depression (MST ... The purpose of this study is to compare the efficacy and side effects magnetic seizure therapy (MST) and electroconvulsive therapy (ECT) in Bipolar ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26075100/

Magnetic Seizure Therapy for Unipolar and Bipolar ... Conclusion: MST was effective in reducing depressive symptoms in mood disorders, with generally less side effects than ECT. No study focused on comparing MST to ...

4. bbrfoundation.org bbrfoundation.org/content/trial-magnetic-seizure-therapy-mst-was-just-effective-electroconvulsive-therapy-ect

In Trial, Magnetic Seizure Therapy (MST) Was Just as ... A trial comparing ECT (electroconvulsive therapy) and MST (magnetic seizure therapy) found that they were equally effective in significantly reducing major ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2817930

Magnetic Seizure Therapy vs Modified Electroconvulsive ... These findings suggest that MST is associated with a high response rate and fewer cognitive impairments in bipolar mania and that it might be an alternative ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5405614/

The Role of Electroconvulsive Therapy (ECT) in Bipolar ... ECT resulted to be an effective and safe treatment for all the phases of severe and drug-resistant BD. Positive response was observed in approximately two- ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2793509

Association of Clinical and Demographic Characteristics ... Meaning This study found that ECT was associated with improvement for mania, with especially high response rates for patients with severe ...

8. europsy.net europsy.net/app/uploads/2024/04/EPA-2024-Electroconvulsive-Therapy-ECT-Press-Release.pdf

Electroconvulsive therapy (ECT) shown to reduce severity ... The Scotland-wide naturalistic study assessed the efficacy and side effects of ECT across a range of common mental illnesses such as depression, ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178121003164

Efficacy and safety of electroconvulsive therapy plus ... ECT-combo outperformed Med-alone in reducing acute manic symptoms in patients with bipolar I disorder. ECT was well tolerated with minimal side effects. With ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3339218/

Clinical profile and outcome of bipolar disorder patients ... Response to electroconvulsive therapy. Nearly 90% of patients in both the subgroups showed more than 50% response (based on reduction in the standardized rating ...