Validation of the University of California San Diego Performance-based Skills Assessment (UPSA) in major depressive disorder: Replication and extension of initial findings.

Background: The University of California San Diego Performance-based Skills Assessment (UPSA) has been validated as a functional measure in patients with major depressive disorder (MDD). The study herein aims to both replicate and extend the initial validation incorporating data sets from two additional studies.

Methods: NCT02279966 and NCT02272517 were multinational, double-blind, placebo-controlled studies in adult outpatients with moderate-to-severe MDD and a current major depressive episode of ≥3 months and less than 1 year, respectively. Subjects were randomized to vortioxetine (10 or 20 mg), placebo or active reference drug (paroxetine [20 mg], or escitalopram [10 or 20 mg]) for 8 weeks. Pearson correlation coefficients were estimated for baseline UPSA-Brief (UPSA-B), demographic/disease characteristics, Montgomery-Åsberg Depression Rating Scale (MADRS), Perceived Deficit Questionnaire-20 items (PDQ-20), and Digit Symbol Substitution Test (DSST), to examine construct validity. Distribution- and anchor-based methods examined clinically important difference (CID) threshold. A pooled analysis with data from NCT01564862 (initial validation study) was performed to increase the statistical power of the estimations.

Results: In pooled analysis of the two new studies, UPSA-B score correlated with the DSST (r = 0.32, P < 0.0001), but not the MADRS (r = -0.07, p = 0.302) or the PDQ-20 (r = -0.10, p = 0.109), replicating initial validation results. Estimated CID range was 7.1-11.2 and 5.5-6.1 points for anchor- and distribution-based methods, respectively. In pooled analyses of all three studies, the CID was 7.0 and 6.4 for anchor- and distribution-based methods, respectively.

Conclusions: These results confirm the construct validity of UPSA for assessing functional capacity in patients with MDD. Estimated CID using UPSA is approximately 6-7 points.

Trial Registration: ClinicalTrials.gov identifier: NCT01564862; NCT02272517; NCT02279966.