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New treatment option for Major Depressive Disorder
Official title E-field Guided iTBS for Treatment Resistant Depression
ClinicalTrials.gov ID: NCT05583747
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- are outpatients;
- are voluntary and competent to consent to treatment;
- have a Diagnostic and Statistical Manual for Mental Disorders, 5th edition major depressive episode based on the Mini International Neuropsychiatric...
- are 18yo to 65yo;
- have a score of ≥18 on the Hamilton Rating Scale for Depression (HRSD-17) item at screening
You likely can't join if
- have a concomitant unstable medical illness
- are pregnant or intend to become pregnant during the study
- have a current MINI diagnosis of bipolar disorder, psychotic disorder, obsessive compulsive disorder, concurrent substance use disorder (aside from...
- have failed a course of electroconvulsive therapy within the current depressive episode due to the lower likelihood of response to rTMS;
- have any significant neurological disorder (e.g., space occupying brain lesion, history of stroke, cerebral aneurysm, seizure disorder, Parkinson's...
- present with a medical condition, medication, or laboratory abnormality that could cause a major depressive episode in the opinion of the investigator
See the full eligibility criteria
- are outpatients;
- are voluntary and competent to consent to treatment;
- have a Diagnostic and Statistical Manual for Mental Disorders, 5th edition major depressive episode based on the Mini International Neuropsychiatric Interview (MINI)
- are 18yo to 65yo;
- have a score of ≥18 on the Hamilton Rating Scale for Depression (HRSD-17) item at screening
- 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...
- are agreeable to keeping their current medication constant during the study
- are able to adhere to the study and treatment schedules
- meet TMS and MRI safety criteria
- have a concomitant unstable medical illness
- are pregnant or intend to become pregnant during the study
- 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...
- have failed a course of electroconvulsive therapy within the current depressive episode due to the lower likelihood of response to rTMS;
- 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...
- present with a medical condition, medication, or laboratory abnormality that could cause a major depressive episode in the opinion of the investigator
- 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
- require benzodiazepine equivalent to lorazepam 2 mg/day or higher or any anticonvulsant due to the potential of these medications to limit the how well it works of rTMS [45]
- have inadequate English fluency to complete clinical assessments.
- are participating in a new course psychotherapy initiated within the last 3 months or finishing prior to the end of scheduled treatments;
- have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.