This proposal seeks to carry out a double-blinded, randomized, comparative study that investigates neurobehavioral changes induced by personalized, anxiosomatic and dysphoric network guided accelerated intermittent-theta burst (iTBS) using dense functional Magnetic Resonance Imaging (fMRI) sampling in participants with treatment-resistant depression (TRD) and moderate/high levels of anxiety.
Male/female aged 21-70
Diagnosis of MDD as validated by MINI
Non-response to adequate trial (4 weeks) of at least two MDD medication as verified by the study clinician
BDI score of 20 or above; BAI score of 16 or above
DSM-5 psychotic disorder
Drug or alcohol abuse or dependence (preceding 3 months)
Rapid clinical response required, e.g., high suicide risk
Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy
Parallel
Individualized connectome-guided accelerated iTBS
DeviceMagpro X100, Axilium Cobot, Localite Camera
Rank- Transformed Ratio of Beck Depression Inventory (BDI) to Beck Anxiety Inventory (BAI) change
The primary outcome will be the rank-transformed ratio of BDI change to BAI change (e.g. A patient has a 50% reduction in BDI and a 25% reduction in BAI, giving a BDI:BAI ratio of 50% ÷ 25% = 2.0. Another patient has a 40% reduction in BDI and a 25% reduction in BAI, giving a BDI:BAI ratio of 40% ÷ 25% = 1.6. Higher ratios indicate a relatively greater improvement in depression compared with anxiety within each patient. This ratio is then ranked across all patients.).
Inventory of Depression and Anxiety Symptoms-II (IDAS-II)
IDAS-II is an ordinal self-report scale measuring depression, anxiety, and bipolar symtpoms ranging from 99-495. Higher scores mean worse outcome.
Penn State Worry Questionnaire (PSWQ)
PSWQ is an ordinal self-report scale measuring pathological worry ranging from 16-80. Scores depend on whether the item is worded positively or negatively.
Interaction between TMS target and change in BDI and BAI
The investigators will test interactions between TMS Target and change in BDI and BAI (including baseline and weekly outcomes over one month) separately using repeated measures linear mixed effects models.
TMS induced changes in resting-fMRI functional connectivity
The investigators will perform additional exploratory post-hoc analyses by analysing brain imaging changes before and after TMS treatment.
Passive physiological metrics
The investigators will also perform additional exploratory post-hoc analyses by analysing passive physiological data collected using an Oura ring throughout the study duration.
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National University Hospital, Singapore
Lead sponsor
National University of Singapore
Collaborator
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