Table 3.
Study efficacy outcome measures
Outcomes | Measure | Time points |
Primary Outcome | 17-Item Hamilton Depression Rating Scale (HDRS-17) | Response at 16 weeks (defined as by a 50% or greater reduction in HDRS-17 score from baseline) |
Secondary Outcomes | HDRS-17 | Mean change in HDRS-17 score compared with baseline at 8, 16 and 26 weeks Response (as defined above) at 8 weeks and at 26 weeks Sustained response at 16 and 26 weeks (defined as a continuing response as defined above following a response at the previous time point) Remitters at 8, 16 and 26 weeks (defined as a score of 7 or less on the HDRS-17) |
Beck Depression Inventory-II | At 8, 16 and 26 weeks | |
Patient Health Questionnaire Quick Inventory of Depressive Symptomatology | At 8, 16 and 26 weeks At 8, 16 and 26 weeks | |
Generalised Anxiety Disorder Assessment | At 8, 16 and 26 weeks | |
THINC Integrated Tool | At 8, 16 and 26 weeks | |
EuroQol-five-Dimensions-five-Level | At 8, 16 and 26 weeks | |
Work and Social Adjustment Scale | At 8, 16 and 26 weeks | |
Patient Acceptability (1–5 scale) | After each TMS session and at 8, 16 and 26 weeks | |
Adverse Events Checklist | After each TMS session and 8 weeks | |
MRI scan (structural (T1), diffusion-weighted imaging (DWI) for structural connectivity, resting state fMRI for functional connectivity (FC) and effective FC (eFC), and GABA MRS of the DLPFC and insula | T1, DWI, FC, eFC at baseline (all centres) GABA at baseline and T1, DWI, FC, eFC, GABA at 16 weeks (all sites except London). |
DLPFC, dorsolateral prefrontal cortex; fMRI, functional MRI; MRS, MR spectroscopy; TMS, transcranial magnetic stimulation.