@article{0b9d02c59b3a49449bd4b91087f72274,
title = "Prediction of acute-phase treatment outcomes by adding a single-item measure of activity impairment to symptom measurement: Development and validation of an interactive calculator from the star∗d and co-med trials",
abstract = "Background: Day-to-day functioning is impaired in major depressive disorder. Yet there are no guidelines to systematically assess these functional changes. This report evaluates prognostic utility of changes in activity impairment to inform clinical decision-making at an individual level. Methods: Mixed model analyses tested changes in activity impairment (sixth item of Work and Activity Impairment scale, rated 0-10) at mid-point (week 6) and end of step 1 (weeks 12-14) in the Sequenced Treatment Alternatives to Relieve Depression (STAR∗D) trial (n = 2697) after controlling for depression severity [Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR)]. Interactive calculators for end of step 1 remission (QIDS-SR ≤5) and no meaningful benefit (<30% QIDS-SR reduction from baseline) were developed for participants with complete data (n = 1476) and independently replicated in the Combining Medications to Enhance Depression Outcomes trial (n = 399). Results: Activity impairment improved independently with acute-phase treatment in STAR∗D (F = 7.27; df = 2,2625; P <. 001). Baseline to mid-point activity impairment change significantly predicted remission (P <. 001, model area under the curve = 0.823) and no meaningful benefit (P <. 001, area under the curve = 0.821) in the STAR∗D trial. Adding activity impairment variables to depression severity measures correctly reclassified 28.4% and 15.8% remitters and nonremitters (net reclassification improvement analysis, P <. 001), and 11.4% and 16.8% of those with no meaningful benefit and meaningful benefit (net reclassification improvement analysis, P <. 001). The STAR∗D trial model estimates accurately predicted remission (area under the curve = 0.80) and no meaningful benefit (area under the curve = 0.82) in the Combining Medications to Enhance Depression Outcomes trial and was used to develop an interactive calculator. Conclusion: A single-item self-report measure of activity impairment changes independently with antidepressant treatment. Baseline to week 6 changes in activity impairment and depression severity can be combined to predict acute-phase remission and no meaningful benefit at an individual level.",
keywords = "Activity impairment, Antidepressant treatment, Major depression, Measurement-based care, Remission, Response prediction, STAR D",
author = "Jha, {Manish K.} and Charles South and Jay Trivedi and Abu Minhajuddin and Rush, {A. John} and Trivedi, {Madhukar H.}",
note = "Funding Information: This work was supported by the National Institute of Mental Health (NIMH), which funded the STAR*D trial (grant no. N01 MH-90003) and the CO-MED trial (grant no. N01 MH090003-02). Funding Information: This work was also supported in part through the Center for Depression Research and Clinical Care at UT Southwestern (Principal Investigator: Madhukar H. Trivedi, MD), The Hersh Foundation, The Jordan Harris Foundation. The content of this publication does not necessarily reflect the views or policies of the U.S. Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US government. National Institute of Mental Health had no role in the drafting or review of the manuscript or in the collection or analysis of the data. Funding Information: Drs. South and Minhajuddin as well as Mr. Trivedi did not have any conflicts of interest. Dr. Jha has received contract research support from Acadia Pharmaceuticals and Janssen Research and Development. Dr. Rush has received consulting fees from Akili, Brain Resource Inc., Compass Inc., Curbstone Consultant LLC, Eli Lilly, Emmes Corp, Liva-Nova, Mind Linc., Sunovion,Takeda USA, Taj Medical; speaking fees from Liva-Nova and Sing-Health; and royalties from Guilford Press and the University of Texas Southwestern Medical Center, Dallas, TX (for the Inventory of Depressive Symptoms and its derivatives). He is also named co-inventor on 2 patents: U.S. Patent No. 7,795,033: Methods to Predict the Outcome of Treatment with Antidepressant Medication, Inventors: McMahon FJ, Laje G, Manji H, Rush AJ, Paddock S, Wilson AS and U.S. Patent No. 7,906,283: Methods to Identify Patients at Risk of Developing Adverse Events During Treatment with Antidepressant Medication,Inventors: McMahon FJ, Laje G, Manji H, Rush AJ, Paddock S. Dr. Trivedi is or has been an advisor/consultant and received fees from: Alkermes, AstraZeneca, Cerecor, Eli Lilly & Company, Lundbeck, Naurex, Neuronetics, Otsuka Pharmaceuticals, Pamlab, Pfizer Inc., SHIRE Development and Takeda. In addition, he has received grants/ research support from National Institute of Mental Health and National Institute on Drug Abuse. Publisher Copyright: {\textcopyright} 2019 The Author(s) 2019. Published by Oxford University Press on behalf of CINP.",
year = "2019",
month = may,
day = "1",
doi = "10.1093/ijnp/pyz011",
language = "English (US)",
volume = "22",
pages = "339--348",
journal = "International Journal of Neuropsychopharmacology",
issn = "1461-1457",
publisher = "Cambridge University Press",
number = "5",
}