Clinical trial NCT04376697: Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study
Official title: Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study in Major Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Disorder
Keywords: rTMS
TMS
repetitive transcranial magnetic stimulation
major depressive disorder
major depression
MDD
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Centre for Addiction and Mental Health
First posted: 2020-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, single-arm, open label feasibility study
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Beck Depression Inventory-II (BDI-II) (score 0-63, higher = more severe)
timeFrame: Baseline (week prior to treatment), on each treatment day, 1 week and 4 weeks post-treatment
Secondary outcomes:
measure: Hamilton Depression Rating Scale 17-items (HDRS17) (score 0-52, higher = more severe)
timeFrame: Baseline (week prior to treatment) and after 1 week and 4 weeks post-treatment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Jonathan Downar
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Miron 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.