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. 2020 Jul 7;10(7):e038430. doi: 10.1136/bmjopen-2020-038430

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.