Comparing Magnetic Seizure Therapy and Electroconvulsive Therapy for Depression
Electroconvulsive Therapy Versus Magnetic Seizure Therapy: Clinical and Cognitive Outcomes
This study is testing if Magnetic Seizure Therapy can help people with Major Depressive Disorder and Bipolar Depression just as well as Electroconvulsive Therapy, but with fewer side effects.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (São Paulo, SP) |
| Trial ID | NCT05054699 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of Magnetic Seizure Therapy (MST) compared to Electroconvulsive Therapy (ECT) for patients with Major Depressive Disorder and Bipolar Depression. MST is an innovative treatment that uses high-frequency magnetic pulses to induce seizures while minimizing cognitive side effects associated with ECT. The study employs a non-inferiority design to determine if MST can provide similar antidepressant effects as ECT while being safer for patients. Additionally, it will assess cognitive side effects and explore neuroimaging changes and predictors of treatment response.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Major Depressive Disorder or Bipolar Depression who have treatment-resistant symptoms.
Not a fit: Patients with other psychiatric conditions or those who have recently undergone ECT or similar treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer alternative to ECT for patients suffering from severe depression.
How similar studies have performed: While ECT has a long history of use, MST is a novel approach, and its comparative efficacy and safety profile are still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Major Depressive Disorder or Bipolar Depression in accordance to the Diagnostic and Statistical Manual (DSM) criteria * Score equal to or great than 17 points on the Hamilton Depression Rating Scale * Treatment-resistant depression, defined as insufficient relief of symptoms after two different first line treatments using therapeutic doses and for four to six weeks * Adequate health and clinical conditions, as assessed by an anaesthesiologist and a psychiatrist Exclusion Criteria: * Pregnancy * Other psychiatric conditions such as Schizophrenia, Schizoaffective Disorder, Substance Abuse, Borderline Personality Disorder, PTSD, or Intellectual Deficiency * Depressive symptoms due to a clinical condition * Any clinical or neurological conditions without proper management * ECT or any other neuromodulation treatment on the last six months * Inability to consent
Where this trial is running
São Paulo, SP
- Institute of Psychiatry, HC-FMUSP — São Paulo, Sp, Brazil (Recruiting)
Study contacts
- Principal investigator: Andre R Brunoni — Faculdade de Medicina Da Usp
- Study coordinator: Andre Brunoni, MD, PhD
- Email: brunoni@usp.br
- Phone: +55-11-2661-8159
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.