VA Aripiprazole vs Esketamine for Treatment Resistant Depression
Status:
Not yet recruiting
Trial end date:
2028-11-01
Target enrollment:
Participant gender:
Summary
This is an open-label, parallel-group, randomized clinical trial of up to 6 months treatment
of adjunctive intranasal (IN) esketamine (ESK) vs. adjunctive aripiprazole (ARI) in Veterans
with unipolar Treatment Resistant Depression (TRD). This study will assess the efficacy,
safety, and acceptability of adjunctive IN ESK in comparison to ARI, one of the best studied
and most widely used adjunctive therapies for TRD. The primary hypothesis is that
participants receiving adjunctive IN ESK will be significantly more likely to achieve
remission after six weeks of treatment as compared to those who receive adjunctive ARI.
Depressive symptoms will be assessed by central raters (CR), blinded to treatment assignment,
using the clinician rated version of the Quick Inventory of Depressive Symptomatology
(QIDS-C16), a well-validated tool that is commonly used and is easily translated across other
depression inventory scales. The study is powered to detect an absolute difference in
remission rates of 10%, or larger, at 6 weeks. Additional outcomes of interest include
symptom reduction across 6 months of randomized therapy, side effects and other tolerability
indices, attrition rates and measures of quality of life and cost-effectiveness.