Table 2 Study efficacy outcome measures
Outcomes | Metric scale | Schedule | |
|---|---|---|---|
Primary outcome | Hamilton Rating Scale for Depression (HRSD) | 24-Item instrument with overall score range of 0–76 | Measured at screening phase as baseline, end of each acute treatment week, and end of every 4 weeks during the follow-up phase |
Secondary outcomes | Montgomery-Asberg Depression Rating Scale (MADRS) | 10-Item instrument with overall score range of 0–60 | Measured at screening phase as baseline, end of each acute treatment week, and end of every 4 weeks during the follow-up phase |
Beck Depression Inventory (BDI) | 21-Item self-report test with overall score range of 0–63 | Measured at screening phase as baseline, end of each acute treatment week, and end of every 4 weeks during the follow-up phase | |
Beck Scale for Suicide Ideation (BSS) | 21-Item self-report test with overall score range of 0–38 with last 2 items not counted in scoring | Measured at screening phase as baseline, end of each acute treatment week, end of each taper week and week 4, and end of every 4 weeks during the follow-up phase | |
Veterans RAND 36-Item Health Survey (VR-36) | A self-administered survey consisting of two parts, i.e. Physical Component Summary (PCS, standardized score range of 0–100) and Mental Component Summary (MCS, standardized score range of 0–100) | Measured at screening phase as baseline, end of the acute treatment phase, and end of the follow-up phase | |
Neuropsychological Battery | A cognitive function test including measures of executive function, attention, memory, visuospatial ability, processing speed, psychomotor function, and premorbid intelligence | Measured at screening phase as baseline, end of the acute treatment phase, and end of the follow-up phase | |