Comparing two types of brain stimulation for major depression
Comparative Effectiveness of Repetitive Versus Deep Transcranial Magnetic Stimulation for Major Depression: A Randomized Controlled Trial
This study is testing whether a new type of brain stimulation called deep transcranial magnetic stimulation (dTMS) works better than the standard type, repetitive transcranial magnetic stimulation (rTMS), for people with major depression who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montréal, Quebec) |
| Trial ID | NCT05902312 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of repetitive transcranial magnetic stimulation (rTMS) and deep transcranial magnetic stimulation (dTMS) in treating treatment-resistant depression (TRD). Participants diagnosed with major depressive disorder will be randomly assigned to receive either rTMS or dTMS. The study seeks to determine if dTMS, which delivers a broader magnetic field, is superior to rTMS in reducing depression symptoms and improving patient outcomes. Additionally, the trial will evaluate potential biomarkers that could predict treatment response.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with major depressive disorder who have not responded to at least two adequate courses of antidepressants.
Not a fit: Patients with a history of substance use disorder, bipolar disorder, or those who have previously received TMS may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients suffering from treatment-resistant depression.
How similar studies have performed: Previous studies have shown promising results for dTMS, but this trial aims to address limitations in earlier research, making it a critical evaluation of these approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Major Depressive Disorder, at least moderate intensity, single or recurrent episode * HRSD-17 score of at least 18 * No improvement to at least two adequate courses of antidepressants (based on the ATHF) or were unable to tolerate at least two separate trials of antidepressants of inadequate dose and duration * On a stable antidepressant regimen for the past four weeks before screening * Patients with a chronic depressive episode \>2 years and who have previously received ECT or ketamine will be eligible to participate Exclusion Criteria: * Having previously received TMS; * Substance use disorder within the last three months * Diagnosis of bipolar or psychosis spectrum disorder * Anxiety or personality disorder that is assessed by a study investigator to be the primary cause and causing greater impairment than MDD * Concomitant major unstable medical or neurological illness * Intracranial implant, cardiac pacemaker or implanted medication pump * Significant laboratory abnormality; * Active suicidal intent * Pregnancy * If participating in psychotherapy, must have been in stable treatment for at least three months before entry into the study, with no anticipation of change * Currently taking more than the equivalent of 2 mg of lorazepam of a benzodiazepine daily or any dose of an anticonvulsant due to the potential to limit TMS effectiveness
Where this trial is running
Montréal, Quebec
- Chum — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Jean-Philippe Miron, MD PhD — Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Study coordinator: Jean-Philippe Miron, MD PhD
- Email: jean-philippe.miron@umontreal.ca
- Phone: 514-890-8000
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.