Patient-reported depression severity and cognitive symptoms as determinants of functioning in patients with major depressive disorder: a secondary analysis of the 2-year prospective PERFORM study

Josep Maria Haro,1 Lene Hammer-Helmich,2 Delphine Saragoussi,3 Anders Ettrup,4 Klaus Groes Larsen51Research and Teaching Unit, Parc Sanitari Sant Joan De Deu, CIBERSAM, University of Barcelona, Sant Boi De Llobregat, Barcelona, Spain; 2Medical Affairs, Real World Evidence, H. Lundbeck A/S, Valby, Denmark; 3Real World Evidence and Epidemiology, Lundbeck SAS, Issy-les-Moulineaux, France; 4Medical Affairs, Vortioxetine, H. Lundbeck A/S, Valby, Denmark; 5Biometrics, H. Lundbeck A/S, Valby, DenmarkPurpose: To investigate the temporal interrelationship between depression severity, cognitive symptoms, and functioning in patients with major depressive disorder (MDD) in the PERFORM study (NCT01427439).Patients and methods: PERFORM was a 2-year, multicenter, prospective, noninterventional cohort study in outpatients with MDD who were either initiating antidepressant monotherapy or undergoing their first switch of antidepressant. Patients were enrolled by a general practitioner or psychiatrist. Structural equation model (SEM) analysis was used to explore temporal associations between patient-reported depression severity (9-item Patient Health Questionnaire score), cognitive symptoms (5-item Perceived Deficits Questionnaire score), and functional impairment (Sheehan Disability Scale total score). Standardized regression coefficients (SRCs) were used to evaluate the relationship between each outcome and scores from the most recent prior visit over the 2 years of follow-up.Results: Between February 25, 2011, and February 19, 2015, 1,159 eligible patients with MDD completed the baseline and ≥1 follow-up visit at 194 sites in five European countries (France, Germany, Spain, Sweden, and the UK). Overall, 1,090 patients had assessments for ≥1 outcome measure at two consecutive visits. Severity of cognitive symptoms at baseline and Months 2 and 18 predicted functional impairment at Months 2, 6, and 24, respectively (SRC: 0.18, 0.15, and 0.22; P