VA Aripiprazole vs Esketamine for Treatment Resistant Depression (VAST-D II)
Open-label, parallel-group, randomised trial (withdrawn; ACTUAL n=0) comparing adjunctive intranasal esketamine versus adjunctive aripiprazole in veterans with treatment-resistant depression over up to 6 months; primary endpoint remission at 6 weeks.
Details
VAST-D II was designed as a multicenter, randomised, open-label, parallel-group study to compare adjunctive intranasal esketamine with adjunctive oral aripiprazole in veterans with unipolar treatment-resistant depression; primary outcome was remission at six weeks assessed by blinded central raters using QIDS-C16.
The trial planned 940 participants across approximately 25 VA medical centres with follow-up visits at weeks 1,2,3,4,6,8,10,12,18 and 24 to assess symptom change, tolerability, attrition, quality of life, and cost-effectiveness; the registry records actual enrolment of 0 and the study was withdrawn.