TY - JOUR
T1 - Using self-reported vocational functioning measures to identify employed patients with impaired functional capacity in major depressive disorder
AU - Murthy, Naga Venkatesha
AU - Xu, Rengyi
AU - Zhong, Wei
AU - Harvey, Philip D.
N1 - Funding Information:
This study was supported by Takeda Pharmaceuticals U.S.A., Inc.
Funding Information:
NVM is a full-time employee of Takeda Pharmaceuticals and owns shares of Takeda and GSK. RX is a full-time employee of Takeda Pharmaceuticals. WZ was an employee of Takeda Pharmaceuticals at the time of study development. PDH has served as a consultant to Akili, Alkermes, Allergan, Biogen, Boehringer Ingelheim, Forum Pharma, Genentech (Roche Pharma), Intra-Cellular Therapies, Lundbeck Pharma, Minerva Pharma, Otsuka America (Otsuka Digital Health), Sanofi Pharma, Sunovion Pharma, Takeda Pharma, and Teva during the past 3 years. He receives royalties from the Brief Assessment of Cognition in Schizophrenia. He has a research grant from Takeda and from the Stanley Medical Research Foundation.
PY - 2020/1/1
Y1 - 2020/1/1
N2 - Background: Patients with major depressive disorder (MDD) show impairments in cognitive functioning, including deficits on performance-based measures of functional capacity. A proportion of patients with MDD may achieve higher scores at baseline, and may not show a detectable response to treatment. How to identify these cases is the goal of this investigation. Methods: Retrospective analyses of data from the CONNECT study with vortioxetine were performed to determine whether the Work Limitations Questionnaire (WLQ) can be used to exclude very high-performing patients on the functional capacity outcome measure, University of California San Diego Performance-Based Skills Assessment (UPSA), in studies evaluating cognitive function impairment in MDD, to identify those with greater potential for treatment response. The post-hoc analyses included data on cognitive function assessed with a Digit Symbol Substitution Test (DSST) from vortioxetine-treated patients. Results: WLQ score >13 identified patients with greater impairments in UPSA-Brief (UPSA-B). Patients with WLQ scores >13, but not with scores ≤13, showed statistically significant improvements with vortioxetine treatment in UPSA-B and DSST compared with placebo. Limitations: Study limitations include small sample size and use of post-hoc analyses. The generalizability of this analysis is limited to working patients with MDD. Conclusions: The WLQ can be used to identify patients with MDD with high potential for treatment response in studies evaluating cognitive function impairment while excluding patients likely to achieve ceiling scores on UPSA. This approach helps identify higher performers on potential outcomes measures without biasing the study by requiring a specific UPSA cutoff score for eligible participants.
AB - Background: Patients with major depressive disorder (MDD) show impairments in cognitive functioning, including deficits on performance-based measures of functional capacity. A proportion of patients with MDD may achieve higher scores at baseline, and may not show a detectable response to treatment. How to identify these cases is the goal of this investigation. Methods: Retrospective analyses of data from the CONNECT study with vortioxetine were performed to determine whether the Work Limitations Questionnaire (WLQ) can be used to exclude very high-performing patients on the functional capacity outcome measure, University of California San Diego Performance-Based Skills Assessment (UPSA), in studies evaluating cognitive function impairment in MDD, to identify those with greater potential for treatment response. The post-hoc analyses included data on cognitive function assessed with a Digit Symbol Substitution Test (DSST) from vortioxetine-treated patients. Results: WLQ score >13 identified patients with greater impairments in UPSA-Brief (UPSA-B). Patients with WLQ scores >13, but not with scores ≤13, showed statistically significant improvements with vortioxetine treatment in UPSA-B and DSST compared with placebo. Limitations: Study limitations include small sample size and use of post-hoc analyses. The generalizability of this analysis is limited to working patients with MDD. Conclusions: The WLQ can be used to identify patients with MDD with high potential for treatment response in studies evaluating cognitive function impairment while excluding patients likely to achieve ceiling scores on UPSA. This approach helps identify higher performers on potential outcomes measures without biasing the study by requiring a specific UPSA cutoff score for eligible participants.
KW - Cognitive impairment
KW - Employment
KW - Functioning
KW - Major depressive disorder
KW - Vortioxetine
UR - http://www.scopus.com/inward/record.url?scp=85072243157&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85072243157&partnerID=8YFLogxK
U2 - 10.1016/j.jad.2019.09.025
DO - 10.1016/j.jad.2019.09.025
M3 - Article
C2 - 31539692
AN - SCOPUS:85072243157
VL - 260
SP - 550
EP - 556
JO - Journal of Affective Disorders
JF - Journal of Affective Disorders
SN - 0165-0327
ER -