Actively Recruiting
E-field Guided iTBS for Treatment Resistant Depression
Led by Centre for Addiction and Mental Health · Updated on 2023-09-26
110
Participants Needed
2
Research Sites
248 weeks
Total Duration
On this page
Sponsors
C
Centre for Addiction and Mental Health
Lead Sponsor
U
University Health Network, Toronto
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to establish how personalization of repetitive transcranial magnetic stimulation (rTMS) can change markers of brain activity and improve treatment response. To do this, all participants will receive the same active form of treatments, but some of the participants in this study will receive intermittent theta burst stimulation (iTBS) rTMS treatment with standard forms of targeting and intensity, and others will receive iTBS rTMS treatment using personalized magnetic resonance imaging (MRI) and electric field (E-field) modeling measures.
CONDITIONS
Official Title
E-field Guided iTBS for Treatment Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Are outpatients
- Voluntary and competent to consent to treatment
- Have a major depressive episode diagnosed by MINI based on DSM-5
- Aged 18 to 65 years old
- Score of 18 or higher on the Hamilton Rating Scale for Depression (HRSD-17) at screening
- No clinical response to an adequate antidepressant dose in current episode or unable to tolerate at least 2 antidepressant trials of inadequate dose/duration
- Agree to keep current medication constant during the study
- Able to follow study and treatment schedules
- Meet safety criteria for TMS and MRI
You will not qualify if you...
- Have an unstable medical illness
- Are pregnant or plan to become pregnant during the study
- Current diagnosis of bipolar disorder, psychotic disorder, OCD, substance use disorder (except nicotine), or PTSD within the past year
- Failed electroconvulsive therapy in current depressive episode
- Significant neurological disorders or diagnosed dementia/cognitive impairment
- Medical condition, medication, or lab abnormality likely causing depression
- Have intracranial implant or unsafe metal in or near the head (excluding mouth)
- Require benzodiazepine equivalent to lorazepam 2 mg/day or higher, or anticonvulsants
- Inadequate English fluency for assessments
- Started new psychotherapy within last 3 months or finishing before end of treatments
- Significant sensory impairment preventing cooperation with interview
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Poul Hansen Family Centre for Depression, Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
2
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J 1H4
Actively Recruiting
Research Team
D
Daphne Voineskos, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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