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Acute and Longer-Term Outcomes in Depressed Outpatients Requiring One or Several Treatment Steps: A STAR*D Report

Objective: This report describes the participants and compares the acute and longer-term treatment outcomes associated with each of four successive steps in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial. Method: A broadly representative adult outpatient sample with nonpsychotic major depressive disorder received one (N = 3,671) to four (N = 123) successive acute treatment steps. Those not achieving remission with or unable to tolerate a treatment step were encouraged to move to the next step. Those with an acceptable benefit, preferably symptom remission, from any particular step could enter a 12-month naturalistic follow-up phase. A score of 5 on the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR₁₆) (equivalent to 7 on the 17-item Hamilton Rating Scale for Depression [HRSD₁₇]) defined remission; a QIDS-SR₁₆ total score of 11 (HRSD₁₇14) defined relapse. Results: The QIDS-SR₁₆ remission rates were 36.8%, 30.6%, 13.7%, and 13.0% for the first, second, third, and fourth acute treatment steps, respectively. The overall cumulative remission rate was 67%. Overall, those who required more treatment steps had higher relapse rates during the naturalistic follow-up phase. In addition, lower relapse rates were found among participants who were in remission at follow-up entry than for those who were not after the first three treatment steps. Conclusions: When more treatment steps are required, lower acute remission rates (especially in the third and fourth treatment steps) and higher relapse rates during the follow-up phase are to be expected. Studies to identify the best multistep treatment sequences for individual patients and the development of more broadly effective treatments are needed.

(Reprinted with permission from the American Journal of Psychiatry 2006; 163:1905–1917)

Dr. Rush has served as an advisor, consultant, or speaker for or received research support from Advanced Neuromodulation Systems, Inc; Best Practice Project Management, Inc.; Bristol-Myers Squibb Company; Cyberonics, Inc.; Eli Lilly & Company; Forest Pharmaceuticals, Inc.; Gerson Lehman Group GlaxoSmithKline; Healthcare Technology Systems, Inc.; Jazz Pharmaceuticals; Merck & Co., Inc.; the National Institute of Mental Health; Neuronetics; Ono Pharmaceutical; Organon USA Inc.; Personality Disorder Research Corp.; Pfizer Inc.; the Robert Wood Johnson Foundation; the Stanley Medical Research Institute; the Urban Institute; and Wyeth-Ayerst Laboratories Inc. He has equity holdings in Pfizer Inc and receives royalty/patent income from Guilford Publications and Healthcare Technology Systems, Inc. Dr. Trivedi has served as an advisor, consultant, or speaker for or received research support from Abbott Laboratories, Inc.; Akzo (Organon Pharmaceuticals Inc.); Bayer; Bristol-Myers Squibb Company; Cephalon, Inc.; Corcept Therapeutics, Inc.; Cyberonics, Inc.; Eli Lilly & Company Forest Pharmaceuticals; GlaxoSmithKline; Janssen Pharmaceutica; Johnson & Johnson PRD; Meade Johnson; the National Institute of Mental Health; the National Alliance for Research in Schizophrenia and Depression; Novartis; Parke-Davis Pharmaceuticals, Inc.; Pfizer Inc; Pharmacia & Upjohn Predix Pharmaceuticals; Sepracor; Solvay Pharmaceuticals, Inc.; and Wyeth-Ayerst Laboratories. Dr. Wisniewski has received research support from the National Institute of Mental Health and served as a advisor/consutlant for /Cyberonics, Inc. Dr. Nierenberg has served as an advisor, consultant, or speaker for or received research support from Bristol-Myers Squibb Company; Cederroth; Cyberonics, Inc.; Eli Lilly & Company; Forest Pharmaceuticals Inc.; Genaissance; GlaxoSmithKline; Innapharma; Janssen Pharmaceutica; Lichtwer Pharma; the National Institute of Mental Health; the National Alliance for Research in Schizophrenia and Depression Neuronetics; Organon, Inc.; Pfizer Inc; Sepracor; Shire; Stanley Foundation; and Wyeth-Ayerst Laboratories. Dr. Stewart has served as an advisor, consultant, or speaker for or received research support from Eli Lilly & Company; GlaxoSmithKline; Organon USA Inc.; Shire; and Somerset. Dr. Warden has received research support from the National Institute of Mental Health and has equity holdings in Bristol-Myer Squibb Company and Pfizer, Inc. Dr. Thase has served as an advisor, consultant, or speaker for AstraZeneca; Bristol-Myers Squibb Company; Cephalon, Inc.; Cyberonics, Inc.; Eli Lilly & Company; Forest Laboratories, Inc.; GlaxoSmithKline; Janssen Pharmaceutica; Eli Lilly & Company; Novartis; Organon, Inc; Pfizer Pharmaceutical; Sanofi Aventis; Sepracor, Inc.; Shire US Inc; and Wyeth Pharmaceuticals. Dr. Lavori has served as an advisor, consultant, or speaker for or received research support from Bristol-Myers Squibb Company; Celera Diagnostics Inc; Cyberonics, Inc.; the Department of Veterans Affairs; Forest Pharmaceuticals, Inc.; GlaxoSmithKline; Leaf Cabrezer Hyman and Bernstein; the National Institutes of Health; and Neuronetics, Inc. Dr. McGrath has served as an advisor, consultant, or speaker for or received research support from Eli Lilly & Company; GlaxoSmithKline; Lipha Pharmaceuticals; the National Institute of Mental Health; the National institute on Alcohol Abuse and Alcoholism; New York State Department of Mental Hygiene; Organon, Inc.; Research Foundation for Mental Hygiene (New York State); and Somerset Pharmaceuticals. Dr. Rosenbaum has served as an advisor, consultant, or speaker for or received research support from Astra-Zeneca; Boehringer-Ingelheim; Bristol-Myers Squibb Company; Cephalon; Compellis; Cyberonics; EPIX; Forest; GlaxoSmithKline; Janssen; Lilly; MedAvante; Neuronetics; Novartis; Orexigen; Organon; Pfizer, Inc; Roche Diagnostics; Sanofi; Schwartz; Somaxon; Somerset; Sepracor; Shire; Supernus; and Wyeth. He has equity holdings in Compellis, Medavante, and Somaxon. Dr. Sackeim has served as an advisor, consultant, or speaker for or received research support from Cyberonics, Inc.; Eli Lilly & Company; Magstim Ltd.; MECTA Corporation; Neurocrine Biosciences Inc; Neuronetics Inc.; NeuroPace Inc; and Pfizer Inc. Dr. Kupfer has served as an advisor, consultant, or speaker for or received research support from Amersham; the Commonwealth of Pennsylvania; Corcept Corporated; Eli Lilly & Company; F. Hoffmann-La Roche Ltd.; Forest Pharmaceuticals; Lundbeck; the National Institute of Mental Health; Novartis; Pfizer, Inc; Servier Amerique; and Solvay/Wyeth. He has equity holdings in Body Media and Med Avante and receives royalty income from Oxford University Press. Dr. Fava has served as an advisor, consultant or speaker for or received research support from Abbott Laboratories; Alkermes; Aspect Medical Systems; Astra-Zeneca; Bayer AG; Biovail Pharmaceuticals, Inc.; BrainCells, Inc.; Bristol-Myers Squibb Company; Cephalon; Compellis; Cypress Pharmaceuticals; Dov Pharmaceuticals; Eli Lilly & Company; EPIX Pharmaceuticals; Fabre-Kramer Pharmaceuticals, Inc.; Forest Pharmaceuticals Inc; GlaxoSmithKline; Grunenthal GmBH; J&J Pharmaceuticals; Janssen Pharmaceutica; jazz Pharmaceuticals; Knoll Pharmaceutical Company; Lichtwer Pharma GmbH; Lorex Pharmaceuticals; Lundbeck; MedAvante, Inc.; Novartis; Nutrition 21; Organon Inc.; PamLab, LLC; Pfizer, Inc; PharmaStar; Pharmavite; Roche; Sanofi/Synthelabo; Sepracor; Solvay Pharmaceuticals, Inc.; Somerset Pharmaceuticals; and Wyeth-Ayerst Laboratories. He has equity holdings in Compellis and MedAvante, Dr. Niederehe, Dr. Lebowitz, and Mr. Luther report no competing interests.

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