title: Assessing the relationship between functional impairment/recovery and depression severity:  a pooled analysis.
abstract: The objective of this study was to explore the relationship between assessments of functional impairment, emotional well-being, and depression symptoms. Data were pooled from 3530 outpatients with major depressive disorder enrolled in 10 desvenlafaxine clinical trials. The primary outcome measures included (a) the 17-item Hamilton Rating Scale for Depression (HAM-D17) as a measure of depressive symptom severity and (b) the Sheehan Disability Scale (SDS) and five-item World Health Organization Well-Being Index (WHO-5) as measures of functional impairment and well-being. A linear regression model was used to identify the SDS and WHO-5 values that equate to the predetermined clinically relevant three-point difference between active treatment and placebo on the HAM-D17. A receiver operating characteristic analysis was conducted to determine the SDS score that equates to a remission of depression symptoms (i.e. HAM-D17≤7). An approximate three-point difference between active treatment and placebo on the SDS (2.8) and WHO-5 (2.5) was determined to be clinically relevant in relation to improvements in depressive symptoms. An SDS of less than or equal to 7 was equivalent to a remission of depression symptoms, providing a definition of functional remission. A better understanding of the relationship between depressive symptoms and functional impairment and well-being may provide clinicians with a more comprehensive means of assessing treatment effects in major depressive disorder.
authors.affiliation: Pfizer Inc., Collegeville, Pennsylvania 19426, USA. christine.guico-pabia@pfizer.com
authors.forename: Christine J
authors.initials: CJ
authors.lastname: Guico-Pabia
authors.forename: Rana S
authors.initials: RS
authors.lastname: Fayyad
authors.forename: Claudio N
authors.initials: CN
authors.lastname: Soares
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003511:Cyclohexanols / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D000069468:Desvenlafaxine Succinate; D004185:Disability Evaluation; D004644:Emotions / Q000187:drug effects; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D016014:Linear Models; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011569:Psychiatric Status Rating Scales; D020127:Recovery of Function; D012074:Remission Induction; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents; D003511:Cyclohexanols; D000069468:Desvenlafaxine Succinate