Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study
1 other identifier
interventional
50
1 country
1
Brief Summary
This prospective, single-arm, open-label feasibility study will assess the safety, tolerability, and effectiveness of repetitive transcranial magnetic stimulation (rTMS) in patients with major depression (MDD) to test the hypothesis that remission rates can be increased by additional treatment sessions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 2019
CompletedFirst Submitted
Initial submission to the registry
April 25, 2020
CompletedFirst Posted
Study publicly available on registry
May 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedDecember 29, 2020
December 1, 2020
1.7 years
April 25, 2020
December 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Beck Depression Inventory-II (BDI-II) (score 0-63, higher = more severe)
Outcome measured by a change in depression score at baseline, before every treatment, and at 1 and 4 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A score of 12 or less is categorized as remission.
Baseline (week prior to treatment), on each treatment day, 1 week and 4 weeks post-treatment
Secondary Outcomes (1)
Hamilton Depression Rating Scale 17-items (HDRS17) (score 0-52, higher = more severe)
Baseline (week prior to treatment) and after 1 week and 4 weeks post-treatment
Study Arms (1)
Active rTMS
EXPERIMENTALTreatment will be delivered daily (weekdays) rTMS treatments, for up to 10 daily sessions and up to 75 sessions in total.
Interventions
The treatment will be delivered by trained medical personnel.
Eligibility Criteria
You may qualify if:
- are outpatients
- are voluntary and competent to consent to treatment
- are between the ages of 18 and 85, inclusive
- are able to adhere to the treatment schedule
- pass the TMS safety-screening questionnaire
- have had no change or initiation of any psychotropic medication in the 4 weeks prior to screening
You may not qualify if:
- previous rTMS treatment
- have a history of substance dependence or abuse within the last 3 months
- have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
- have active suicidal intent
- have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
- have a diagnosis of any psychotic disorder
- have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure confirmed diagnostically by neurological assessment (except those therapeutically induced by ECT), cerebral aneurysm, Parkinson's disease, Huntington's chorea, dementia, stroke, neurologically confirmed diagnosis of traumatic brain injury, or multiple sclerosis.
- if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
- clinically significant laboratory abnormality, in the opinion of the investigator
- currently (or in the last 4 weeks) take more than lorazepam 4 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
- non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)
- any significant cardiovascular or metabolic disorder or insult including, but not limited to: coronary artery disease, abnormal heart rhythms, heart failure, cardiac valve disease, congenital heart disease, cardiomyopathy, vascular disease, dyslipidemia, diabetes, or hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto Western Hospital
Toronto, Ontario, M5T2S8, Canada
Related Publications (2)
Sheen JZ, Miron JP, Mansouri F, Dunlop K, Russell T, Zhou R, Hyde M, Fox L, Voetterl H, Daskalakis ZJ, Griffiths JD, Blumberger DM, Downar J. Cardiovascular biomarkers of response to accelerated low frequency repetitive transcranial magnetic stimulation in major depression. J Affect Disord. 2022 Dec 1;318:167-174. doi: 10.1016/j.jad.2022.08.105. Epub 2022 Aug 31.
PMID: 36055538DERIVEDMiron JP, Voetterl H, Fox L, Hyde M, Mansouri F, Dees S, Zhou R, Sheen J, Desbeaumes Jodoin V, Mir-Moghtadaei A, Blumberger DM, Daskalakis ZJ, Vila-Rodriguez F, Downar J. Optimized repetitive transcranial magnetic stimulation techniques for the treatment of major depression: A proof of concept study. Psychiatry Res. 2021 Apr;298:113790. doi: 10.1016/j.psychres.2021.113790. Epub 2021 Feb 7.
PMID: 33581379DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Downar
University Health Network, Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinician scientist
Study Record Dates
First Submitted
April 25, 2020
First Posted
May 6, 2020
Study Start
March 18, 2019
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
December 29, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share