Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-12-15
2028-06-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Standard rTMS
rTMS using standard targeting (Beam-F3) will be delivered
Accelerated rTMS
rTMS targeting will be done using the standard Beam-F3 targeting method. Treatment will be delivered in an accelerated schedule with 50 treatment session over 5 days.
Parcel-guided rTMS
rTMS will be delivered using brain-surface parcellation targeting
Parcel-guided Accelerated rTMS
rTMS targeting will be done using brain surface parcellation. Treatment will be delivered in an accelerated schedule with 50 treatment sessions over 5 days.
Interventions
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Accelerated rTMS
rTMS targeting will be done using the standard Beam-F3 targeting method. Treatment will be delivered in an accelerated schedule with 50 treatment session over 5 days.
Parcel-guided Accelerated rTMS
rTMS targeting will be done using brain surface parcellation. Treatment will be delivered in an accelerated schedule with 50 treatment sessions over 5 days.
Eligibility Criteria
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Inclusion Criteria
* Treatment-resistant MDD during the current major depressive episode documented in the MGH Antidepressant Treatment History Questionnaire (ATRQ31), which will be defined as being non-responders (less than 50% of symptom improvement) to two or more depression treatment trials of adequate dose and duration as defined by the MGH ATRQ.
* At least moderate depression severity, operationalized as Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20
Exclusion Criteria
* Anorexia nervosa or bulimia nervosa within the last year
* Unstable medical condition by history, physical exam or laboratory results
* Currently pregnant or breastfeeding women; fecund women not using adequate contraceptive methods or with plan to become pregnant
* Contraindications to MRI (based on metal screening form)
* Meets criteria for claustrophobia
* Recent drug or alcohol use disorder with DSM-5 specifier of moderate or severe within 6 months, or mild within 2 months; or lifetime history of IV drug use A- ctively suicidal, as defined by expressive ideation with a plan or with suicidal ideation that requires immediate medical or treatment intervention.
* Neurological or neuromuscular disorder
* Requires medications for a general medical condition that contraindicate the TMS treatment
* Prior non-response to ECT, vagal nerve stimulation (VNS) or deep brain stimulation (DBS)
* History of ketamine treatment within 6 months
* History of monoamine oxidase inhibitor (MAOI) within the past month
* Lacks capacity to consent
* Taking medications that increase the risk of seizures.
* For patients on permitted concomitant psychotropic agents (antidepressants, anticonvulsants, benzodiazepines, hypnotics, opiates, triiodothyronine (T3), modafinil, psychostimulants, buspirone, melatonin, omega-3 fatty acids, folate, l-methylfolate, s-adenosyl methionine, lithium) dosing must be stable for at least four weeks prior to study entry and patients must agree to continue at the same dose during the study
18 Years
60 Years
ALL
No
Sponsors
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Columbia University Irving Medical Center, New York, NY
UNKNOWN
Soterix Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Abhishek Datta, PhD
Role: PRINCIPAL_INVESTIGATOR
Soterix Medical, Inc.
Central Contacts
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References
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Moreno-Ortega M, Kangarlu A, Lee S, Perera T, Kangarlu J, Palomo T, Glasser MF, Javitt DC. Parcel-guided rTMS for depression. Transl Psychiatry. 2020 Aug 12;10(1):283. doi: 10.1038/s41398-020-00970-8.
Other Identifiers
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RTMSP2
Identifier Type: -
Identifier Source: org_study_id