NCT05583747 E-field Guided iTBS for Treatment Resistant Depression
| NCT ID | NCT05583747 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre for Addiction and Mental Health |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2022-10-24 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2022-10-24 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05583747 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05583747 currently recruiting?
Yes, NCT05583747 is actively recruiting participants. Contact the research team at daphne.voineskos@camh.ca for enrollment information.
Where is the NCT05583747 trial being conducted?
This trial is being conducted at Toronto, Canada, Toronto, Canada.
Who is sponsoring the NCT05583747 clinical trial?
NCT05583747 is sponsored by Centre for Addiction and Mental Health. The trial plans to enroll 110 participants.