Personalized brain stimulation for treatment-resistant depression
Electrical Field Modeling to Engage Neurophysiological Targets of Intermittent Theta Burst Stimulation in Treatment Resistant Depression (E-Fields iTBS)
This study is testing if a personalized brain stimulation treatment can help people with treatment-resistant depression feel better compared to standard methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Centre for Addiction and Mental Health Academic / other |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT05583747 on ClinicalTrials.gov |
What this trial studies
This study aims to explore how personalized repetitive transcranial magnetic stimulation (rTMS) can enhance treatment response in patients with major depressive disorder. Participants will receive up to 30 sessions of intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex, with some receiving standard treatment and others receiving personalized treatment based on MRI and electric field modeling. The study will assess changes in brain activity markers and overall treatment efficacy. Participants will be monitored over a six-week period, receiving treatment five days a week.
Who should consider this trial
Good fit: Ideal candidates are outpatients aged 18 to 65 with major depressive disorder who have not responded to previous antidepressant treatments.
Not a fit: Patients with unstable medical illnesses or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with treatment-resistant depression.
How similar studies have performed: Other studies have shown promise with personalized brain stimulation approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. are outpatients; 2. are voluntary and competent to consent to treatment; 3. have a Diagnostic and Statistical Manual for Mental Disorders, 5th edition major depressive episode based on the Mini International Neuropsychiatric Interview (MINI) 4. are 18yo to 65yo; 5. have a score of ≥18 on the Hamilton Rating Scale for Depression (HRSD-17) item at screening 6. have not had a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of ≥ 3 in the current episode or have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2); 7. are agreeable to keeping their current medication constant during the study 8. are able to adhere to the study and treatment schedules 9. meet TMS and MRI safety criteria Exclusion Criteria: 1. have a concomitant unstable medical illness 2. are pregnant or intend to become pregnant during the study 3. have a current MINI diagnosis of bipolar disorder, psychotic disorder, obsessive compulsive disorder, concurrent substance use disorder (aside from nicotine) or post-traumatic stress disorder (current or within the last year) 4. have failed a course of electroconvulsive therapy within the current depressive episode due to the lower likelihood of response to rTMS; 5. have any significant neurological disorder (e.g., space occupying brain lesion, history of stroke, cerebral aneurysm, seizure disorder, Parkinson's disease, Huntington's chorea, multiple sclerosis) or confirmed diagnosis of dementia or cognitive impairment 6. present with a medical condition, medication, or laboratory abnormality that could cause a major depressive episode in the opinion of the investigator 7. have an intracranial implant or any other metal object that cannot be safely removed, precluding safety of TMS or MRI exposure within or near the head, excluding the mouth 8. require benzodiazepine equivalent to lorazepam 2 mg/day or higher or any anticonvulsant due to the potential of these medications to limit the efficacy of rTMS \[45\] 9. have inadequate English fluency to complete clinical assessments. 10. are participating in a new course psychotherapy initiated within the last 3 months or finishing prior to the end of scheduled treatments; 11. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
Where this trial is running
Toronto, Ontario and 1 other locations
- Poul Hansen Family Centre for Depression, Toronto Western Hospital — Toronto, Ontario, Canada (Recruiting)
- Centre for Addiction and Mental Health — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Daphne Voineskos, MD
- Email: daphne.voineskos@camh.ca
- Phone: 416-535-8501
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.