Depression Clinical Trial
Official title:
Canadian rTMS Treatment and Biomarker Network in Depression Trial
Repetitive transcranial magnetic stimulation (rTMS) is an emerging treatment for medically
refractory major depressive disorder (MDD). rTMS involves direct stimulation of cortical
neurons using externally applied, powerful, focused magnetic field pulses. Dozens of studies
and several meta-analyses over the last 15 years have shown that rTMS of the dorsolateral
prefrontal cortex (DLPFC) produces statistically significant improvements in MDD, even when
medications have failed. However, other possible targets may also yield improvement in
symptoms.
In an attempt to enhance the therapeutic efficacy of current interventions for TRD, attention
has turned to identifying domain-specific biomarkers in hopes of ultimately individualizing
and predicting treatment response. Unfortunately, the precise nature of this relationship is
less than clear, as reflected by the fact that even now there are no established biomarkers
that are used routinely in clinical practice to aid in diagnosis. This study also seeks to
examine a comprehensive suite of biomarker measurements (MRI, neurophysiology, and
genomics/proteomics) before and after rTMS treatment.
rTMS is a Health-Canada- and FDA-approved treatment for treatment-resistant depression (TRD), using focused magnetic field pulses to stimulate brain regions involved in emotion regulation, safely and non-invasively. Though rTMS is often effective where medications or therapy fail, it requires a series of lengthy (~30-40 min) treatment sessions. A new form of rTMS called theta burst stimulation (TBS) has been shown to have greater effects on neural activity than conventional stimulation, despite requiring as little as 40 s of stimulation. The purpose of this study is to assess the efficacy and tolerability of an accelerated TBS protocol, administered 2 times a day in patients with TRD. In addition, the investigators aim to identify candidate biomarkers from a multimodal suite of neuroimaging, neurophysiologic and molecular measures that are predictors and correlates of response to rTMS treatment. ;
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