What side effects are associated with this type of intervention?

Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) are treatments for Major Depressive Disorder that induce seizures to alleviate symptoms. ECT is associated with cognitive side effects such as memory loss, confusion, and disorientation, which can be temporary or persistent. MST, on the other hand, tends to have fewer cognitive side effects, with minimal impact on cognitive performance. Both therapies can cause physical side effects like headaches, muscle aches, and nausea.

What prior FDA approvals exist?

The FDA has approved Electroconvulsive Therapy (ECT) for the treatment of Major Depressive Disorder, particularly in cases where patients are resistant to other forms of treatment. ECT uses electrical currents to induce seizures, which can provide rapid relief from severe depressive symptoms. While Magnetic Seizure Therapy (MST) is still investigational and not yet FDA-approved, it operates on a similar principle by using magnetic fields to induce seizures. Both therapies are considered when traditional pharmacotherapy and psychotherapy have failed to yield adequate results.

What other types of research exist?

Promising, novel alternatives to MST and ECT for Major Depressive Disorder patients include repetitive transcranial magnetic stimulation (rTMS), transcranial direct-current stimulation (tDCS), vagus nerve stimulation (VNS), and deep brain stimulation (DBS). These therapies have shown potential in clinical studies and may offer effective treatment options for patients in 2024.

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Convulsive Therapy

Convulsive Therapies for Depression (CORRECT-C Trial)

N/A

Recruiting

Led By Daniel Blumberger, MD, MSc

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

achieve remission defined as HRSD-24 < 10 and a > 60% decrease in scores from baseline on two consecutive ratings OR achieve response on HRSD-24 defined as a 50% reduction in symptoms from baseline

are 18 years of age or older

Must not have

have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm

require a benzodiazepine with dose greater than lorazepam 2 mg/day or equivalent or any anticonvulsant due to the potential of these medications to limit the efficacy of both MST and ECT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how well MST and two types of ECT work in keeping depression from coming back in patients who felt better after these treatments before. It also includes patients who didn't feel better initially and are given another form of ECT. Magnetic Seizure Therapy (MST) is shown to be as effective as Electroconvulsive Therapy (ECT) in treating depression, with MST having better effects on thinking skills.

Who is the study for?

This trial is for adults who've been diagnosed with depression or bipolar disorder and have responded to initial bitemporal ECT treatment. They must be able to consent, maintain current antidepressant use, adhere to the schedule, meet safety criteria for MST, and not be pregnant. Exclusions include dementia, metal implants in the head, significant sensory impairments or unstable medical conditions.

What is being tested?

The study compares Magnetic Seizure Therapy (MST) with two types of electroconvulsive therapy (ECT): Bitemporal ECT and RUL-UB ECT. It aims to determine which method best maintains response in patients during continuation treatment after an acute phase of depression or bipolar disorder.

What are the potential side effects?

Potential side effects may include memory issues, confusion immediately after treatments, physical side effects like muscle aches or headaches from convulsions induced by therapies. Each individual's experience can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My depression symptoms have significantly improved.

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I am 18 years old or older.

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 major brain disorders or conditions that could increase pressure inside my skull.

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I need a strong medication for anxiety or seizures, more than 2 mg/day of lorazepam or its equivalent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT)

Difference in HRSD-24 Scores between MST and RUL-UB at 6 months

Secondary study objectives

Differences in HRSD-24 scores between MST, RUL-UB ECT and bitemporal ECT

Electroconvulsive Therapy

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Magnetic Seizure Therapy (MST)Experimental Treatment1 Intervention

MST treatments will be administered using the MagPro MST with Cool TwinCoil.

Group II: RUL-UB ECTActive Control1 Intervention

ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma

Group III: Bitemporal ECTActive Control1 Intervention

ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma

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

Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) are neuromodulation treatments for Major Depressive Disorder (MDD) that work by inducing controlled seizures. ECT uses electrical currents, while MST uses magnetic fields to stimulate the brain. These seizures are believed to cause changes in brain chemistry, including the release of neurotransmitters like serotonin, norepinephrine, and dopamine, which are often imbalanced in depression. Additionally, these therapies may promote neuroplasticity, enhancing the brain's ability to adapt and form new connections. Understanding these mechanisms is crucial for MDD patients as it highlights the potential for rapid and significant symptom relief, especially in cases where traditional pharmacotherapy has failed.

Neuroactive steroids as modulators of depression and anxiety.