@article{933c8754ef4d45bab70207a10fe55e3d,
title = "A Characterization of the Clinical Global Impression Scale Thresholds in the Treatment of Adolescent Depression Across Multiple Rating Scales",
abstract = "Introduction: The Clinical Global Impressions-Improvement (CGI-I) scale is widely used in clinical research to assess symptoms and functioning in the context of treatment. The correlates of the CGI-I with efficacy scales for adolescent major depressive disorder are poorly understood. This study focused on benchmarking CGI-I scores with changes in the Children's Depression Rating Scale-Revised (CDRS-R) and the Quick Inventory of Depressive Symptomatology-Adolescent (17-item) Self-Report (QIDS-A17-SR). Methods: We examined three datasets with the clinician-rated CDRS-R to ascertain equivalent percent changes in total scores and CGI-I ratings. Exploratory analyses examined corresponding percentage changes in the QIDS-A17-SR and the CGI-I ratings. The CGI-I was the reference scale for nonparametric equipercentile linking with the Equate package in R. Results: CGI-I scores of 1 mapped to ≥78%-95% change in CDRS-R scores at 4-6 weeks across three datasets. CGI-I scores of 2 mapped to 56%-94% change in CDRS-R scores at 4-6 weeks across three studies. CGI-I scores of 3 mapped to 30%-68% changes in CDRS-R scores at 4-6 weeks across three studies. CGI-I scores of 4 mapped to a range of 29%-44% at 4-6 weeks across three studies. There was no significant difference (p ≥ 0.6) between treatment groups in both the Treatment of Adolescents with Depression and Treatment of Resistant Depression in Adolescents studies, for each CGI-I score (= 1, or = 2 or = 3, or ≥4), associated mapping of total depression severity score, or associated percent change from baseline for corresponding follow-up visits. There was no significant sex difference (p > 0.2) in CGI-I linkages to CDRS-R total or percentage changes. Conclusions: These findings establish clear relationships among CGI-I scores and the CDRS-R and the QIDS-A17-SR. These benchmarks have utility for clinical trial study design, inter-rater reliability training, and clinical implementation.",
keywords = "AMOD, Equipercentile linking, Remission, Response, TADS, TORDIA",
author = "Zhang, {Carl Y.} and Voort, {Jennifer L.Vande} and Deniz Yuruk and Mills, {Jeffrey A.} and Emslie, {Graham J.} and Kennard, {Betsy D.} and Taryn Mayes and Madhukar Trivedi and Bobo, {William V.} and Strawn, {Jeffrey R.} and Athreya, {Arjun P.} and Croarkin, {Paul E.}",
note = "Funding Information: G.J.E. is a consultant for Lundbeck, Neuronetics, and Otsuka. B.D.K. receives royalties from Guilford Press, Inc., M.T. has provided consulting services to Acadia Pharmaceuticals, Inc., Alkermes, Inc., Allergan, Inc., Alto Neuroscience, Inc., Applied Clinical Intelligence, Axsome Therapeutics, Boehringer In-gelheim, Engage Health Media, GH Research Limited, GreenLight VitalSign6, Inc., Health Care Global Village, Janssen, Merck Sharp & Dohme Corp., Myriad Neuroscience, Navitor Pharmaceutical, Inc., Neurocrine Biosciences, Inc., Orexo US, Inc., Otsuka, Perception Neuroscience, Pharmerit International, SAGE Therapeutics, Signant Health, and Titan Pharmaceuticals, Inc. He has received grant/research funding from NIMH, NIDA, Patient-Centered Outcomes Research Institute (PCORI), and Cancer Prevention Research Institute of Texas (CPRIT). Funding Information: J.L.V.V. was a co-primary investigator on an investigator-initiated study that had grant-in-kind support for supplies and genotyping from Assurex Health. J.A.M. receives research support from the Yung Family Foundation. G.J.E. receives research support from Duke University, Forest Research Institute (partner of Merck KGaA; formerly known as Forest Laboratories), and Janssen Pharmaceuticals, Research & Development. Funding Information: 1Department of Molecular Pharmacology and Experimental Therapeutics, Mayo Clinic, Rochester, Minnesota, USA. 2Department of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota, USA. 3Department of Economics, University of Cincinnati, Cincinnati, Ohio, USA. 4Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas, USA. 5Children{\textquoteright}s Health, Children{\textquoteright}s Medical Center, Dallas, Texas, USA. 6Department of Psychiatry and Psychology, Mayo Clinic, Jacksonville, Florida, USA. 7Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati, Cincinnati, Ohio, USA. Funding: This work was, in part, supported by the Mayo Clinic{\textquoteright}s Summer Undergraduate Research Fellowship, Mayo Clinic Foundation for Medical Education and Research, the National Science Foundation under award number 2041339, and the National Institutes Health under award numbers R01MH113700, R01MH124655, and R01AA027486. The sources of funding for this study had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the article; and in the decision to publish the results. *These authors contributed equally to this work. Funding Information: P.E.C. has received research grant support from Mayo Foundation for Education and Research, Neuronetics, Inc.; NeoSync, Inc.; NSF, NIMH, and Pfizer, Inc. He has received grant-in-kind (equipment support for research studies) from Assurex; MagVen-ture, Inc; and Neuronetics, Inc. He has served as a consultant for Engrail Therapeutics, Myriad Neuroscience, Procter & Gamble, and Sunovion. The other authors have no disclosure or potential conflict of interests. Publisher Copyright: {\textcopyright} 2022, Mary Ann Liebert, Inc., publishers.",
year = "2022",
month = jun,
day = "1",
doi = "10.1089/cap.2021.0111",
language = "English (US)",
volume = "32",
pages = "278--287",
journal = "Journal of Child and Adolescent Psychopharmacology",
issn = "1044-5463",
publisher = "Mary Ann Liebert Inc.",
number = "5",
}