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Primary Versus Specialty Care Outcomes for Depressed Outpatients Managed with Measurement-Based Care: Results from STAR*D

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Abstract

Background

Whether the acute outcomes of major depressive disorder (MDD) treated in primary (PC) or specialty care (SC) settings are different is unknown.

Objective

To compare the treatment and outcomes for depressed outpatients treated in primary versus specialty settings with citalopram in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study (www.star-d.org), a broadly inclusive effectiveness trial.

Design

Open clinical trial with citalopram for up to 14 weeks at 18 primary and 23 specialty sites. Participants received measurement-based care with 5 recommended treatment visits, manualized pharmacotherapy, ongoing support and guidance by a clinical research coordinator, the use of structured evaluation of depressive symptoms and side effects at each visit, and a centralized treatment monitoring and feedback system.

Participants

A total of 2,876 previously established outpatients in primary (n = 1091) or specialty (n = 1785) with nonpsychotic depression who had at least 1 post-baseline measure.

Measurements and Main Results

Remission (Hamilton Depression Rating Scale for Depression [Hamilton] or 16-item Quick Inventory of Depressive Symptomatology-Self-Rated [QIDS-SR16]); response (QIDS-SR16); time to first remission (QIDS-SR16). Remission rates by Hamilton (26.6% PC vs 28.0% SC, p = .40) and by QIDS-SR16 (32.5% PC vs 33.1% SC, p = .78) and response rates by QIDS-SR16 (45.7% PC vs 47.6% SC, p = .33) were not different. For those who reached remission or response at exit, the time to remission (6.2 weeks PC vs 6.9 weeks SC, p = .12) and to response (5.5 weeks PC vs 5.4 weeks SC, p = .97) did not differ by setting.

Conclusions

Identical remission and response rates can be achieved in primary and specialty settings when identical care is provided.

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ACKNOWLEDGMENTS

We would like to thank the STAR*D investigators for all the help in making this large and complex multicenter study possible and for generating the data for this report. We would also like to acknowledge the editorial support of Jon Kilner, MS, MA (Pittsburgh, Pennsylvania) and the secretarial support of Fast Word Information Processing Inc. (Dallas, Texas).

This project has been funded with Federal funds from the National Institute of Mental Health, National Institutes of Health, under Contract N01MH90003 to UT Southwestern Medical Center at Dallas (P.I.: A.J. Rush). Dr. Gaynes was supported in part by an NIMH K23 Career Development Award (MH01951-03). The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does the mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government. The authors’ work was independent of the funders (i.e., the funders had no involvement in the collection, analysis, and interpretation of data nor in the writing of this report or the decision to submit the article).

Conflict of Interest

Bradley N. Gaynes, MD, MPH

Dr. Gaynes has received grants and research support from the National Institute of Mental Health; Agency for Healthcare Research and Quality; Robert Wood Johnson Foundation; the M—3 Corporation; Bristol-Myers Squibb Company; Novartis; Pfizer, Inc.; and Ovation Pharmaceuticals. He has performed as an advisor or consultant for Pfizer, Inc.; Shire Pharmaceuticals; and Wyeth-Ayerst. He has also received a speaker’s honorarium from GlaxoSmithKline.

A. John Rush, MD

Dr. Rush has provided scientific consultation to or served on Advisory Boards for Advanced Neuromodulation Systems, Inc.; Best Practice Project Management, Inc.; Bristol-Myers Squibb Company; Cyberonics, Inc.; Forest Pharmaceuticals, Inc.; Gerson Lehman Group; GlaxoSmithKline; Jazz Pharmaceuticals; Eli Lilly & Company; Magellan Health Services; Merck & Co., Inc.; Neuronetics; Ono Pharmaceutical; Organon USA Inc.; Pamlab; Personality Disorder Research Corp.; Pfizer Inc.; The Urban Institute; and Wyeth-Ayerst Laboratories Inc. He has received royalties from Guilford Press and Health Technology Systems and research/grant support from the Robert Wood Johnson Foundation, the National Institute of Mental Health, the National Institutes of Health, and the Stanley Foundation; has been on speaker bureaus for Cyberonics, Inc., Forest Pharmaceuticals Inc., GlaxoSmithKline, and Eli Lilly & Company; and owns stock in Pfizer Inc.

Madhukar H. Trivedi, MD

Dr. Trivedi has received research support from Bristol-Myers Squibb Company; Cephalon, Inc.; Corcept Therapeutics, Inc.; Cyberonics, Inc.; Eli Lilly & Company; Forest Pharmaceuticals; GlaxoSmithKline; Janssen Pharmaceutica; Merck; National Institute of Mental Health; National Alliance for Research in Schizophrenia and Depression; Novartis; Pfizer Inc.; Pharmacia & Upjohn; Predix Pharmaceuticals; Solvay Pharmaceuticals, Inc.; and Wyeth-Ayerst Laboratories. He has served as an advisor or consultant for Abbott Laboratories, Inc.; Akzo (Organon Pharmaceuticals Inc.); Astra-Zeneca; Bayer; Bristol-Myers Squibb Company; Cephalon, Inc.; Cyberonics, Inc.; Fabre-Kramer Pharmaceuticals, Forest Pharmaceuticals; GlaxoSmithKline; Janssen Pharmaceutica Products, LP; Johnson & Johnson PRD; Eli Lilly & Company; Meade Johnson; Parke-Davis Pharmaceuticals, Inc.; Pfizer, Inc.; Pharmacia & Upjohn; Sepracor; Solvay Pharmaceuticals, Inc.; VantagePoint; and Wyeth-Ayerst Laboratories. He has received speaker honoraria from Abdi Brahim; Akzo (Organon Pharmaceuticals Inc.); Bristol-Myers Squibb Company; Cephalon, Inc.; Cyberonics, Inc.; Forest Pharmaceuticals; GlaxoSmithKline; Janssen Pharmaceutica Products, LP; Eli Lilly & Company; Pharmacia & Upjohn; Solvay Pharmaceuticals, Inc.; and Wyeth-Ayerst Laboratories.

Maurizio Fava, MD

Dr. Fava has received research support from Abbott Laboratories, Alkermes, Aspect Medical Systems, Astra-Zeneca, Bristol-Myers Squibb Company, Cephalon, Eli Lilly & Company, Forest Pharmaceuticals Inc., GlaxoSmithKline, J & J Pharmaceuticals, Lichtwer Pharma GmbH, Lorex Pharmaceuticals, Novartis, Organon Inc., PamLab, LLC, Pfizer Inc, Pharmavite, Roche, Sanofi/Synthelabo, Solvay Pharmaceuticals, Inc., and Wyeth-Ayerst Laboratories. He has served on Advisory Boards and done Consulting for Aspect Medical Systems, Astra-Zeneca, Auspex Pharmaceuticals, Bayer AG, Best Practice Project Management, Inc., Biovail Pharmaceuticals, Inc., BrainCells, Inc. Bristol-Myers Squibb Company, Cephalon, Compellis, CNS Response, Cypress Pharmaceuticals, Dov Pharmaceuticals, Eli Lilly & Company, EPIX Pharmaceuticals, Fabre-Kramer Pharmaceuticals, Inc., Forest Pharmaceuticals Inc., GlaxoSmithKline, Grunenthal GmBH, Janssen Pharmaceutica, Jazz Pharmaceuticals, J & J Pharmaceuticals, Knoll Pharmaceutical Company, Lundbeck, MedAvante, Inc., Merck, Neuronetics, Novartis, Nutrition 21, Organon Inc., PamLab, LLC, Pfizer Inc, PharmaStar, Pharmavite, Precision Human Biolaboratory, Roche, Sanofi/Synthelabo, Sepracor, Solvay Pharmaceuticals, Inc., Somaxon, Somerset Pharmaceuticals, Takeda, TetraGenex Inc., Transcept Pharmaceuticals, and Wyeth-Ayerst Laboratories. Dr. Fava has served on the speaker’s bureau for Astra-Zeneca, Boehringer-Ingelheim, Bristol-Myers Squibb Company, Cephalon, Eli Lilly & Company, Forest Pharmaceuticals Inc., GlaxoSmithKline, Novartis, Organon Inc., Pfizer Inc, PharmaStar, and Wyeth-Ayerst Laboratories. He has equity in Compellis and MedAvante.

Andrew A. Nierenberg, MD

Dr. Nierenberg has provided scientific consultation for BrainCells, Inc., Bristol-Myers Squibb, Eli Lilly & Company, Genaissance, GlaxoSmithKline, Innapharma, Janssen Pharmaceutica, Novartis, Pfizer, Sepracor, Shire, and Somerset, and has received research support from Bristol-Myers Squibb Company, Cederroth, Cyberonics, Inc., Forest Pharmaceuticals Inc., GlaxoSmithKline, Janssen Pharmaceutica, Lichtwer Pharma, Eli Lilly & Company, NARSAD, NIH, Pfizer Inc., the Stanley Foundation, and Wyeth-Ayerst. Dr. Nierenberg has received honoraria from Bristol-Myers Squibb, Cyberonics, Forest Pharmaceuticals, Eli Lilly & Company, GlaxoSmithKline, and Wyeth-Ayerst Laboratories.

Stephen R. Wisniewski, PhD

Dr. Wisniewski has received grants and research support from the National Institute of Mental Health. He has performed as a consultant for Cyberonics Inc., ImaRx Therapeutics, Inc., Bristol-Myers Squibb Company, Organon, and Case-Western University.

G.K. Balasubramani, PhD.

None disclosed.

Patrick J. McGrath, MD

Dr McGrath has received research support from the National Institute of Mental Health; National Institute on Alcohol Abuse and Alcoholism; New York State Department of Mental Hygiene; Research Foundation for Mental Hygiene (New York State); GlaxoSmithKline; Eli Lilly; and Organon. He has been an advisor or consultant for GlaxoSmithKline, Lipha Pharmaceuticals, Novartis, and Somerset Pharmaceuticals.

Michael E. Thase, MD

Dr. Thase has provided scientific consultation to Astra-Zeneca, Bristol-Myers Squibb Company, Cephalon, Cyberonics, Inc., Eli Lilly & Company, Forest Pharmaceuticals, Inc., GlaxoSmithKline, Janssen Pharmaceutica, MedAvante, Inc., Neuronetics, Inc., Novartis, Organon, Inc., Sepracor Inc., Shire US Inc., Supernus Pharmaceuticals, and Wyeth-Ayerst Laboratories. Dr. Thase has been on the speakers’ bureaus for AstraZeneca, Bristol-Myers Squibb Company, Cyberonics, Inc., Eli Lilly & Company, GlaxoSmithKline, Organon, Inc., Sanofi Aventis, and Wyeth-Ayerst Laboratories. Dr. Thase has equity holdings in MedAvante, Inc. and receives royalty income from American Psychiatric Publishing, Inc., Guilford Publications, and Herald House. He has provided expert testimony for Jones Day and Philips Lyttle, LLP.

Michael Klinkman, MD

Dr. Klinkman has received grants and research support from the National Institutes of Health (Roadmap initiative), the National Institute of Mental Health, Agency for Healthcare Research and Quality, Robert Wood Johnson Foundation, Lilly Foundation, and the Michigan BlueCross/Blue Shield Foundation. He has served on an advisory panel for Wyeth Pharmaceuticals.

William R. Yates, MD

Dr. Yates has received grants and research support from Eli Lilly and Company and Forest Laboratories. He has performed as an advisor or consultant for Eli Lilly and Company, Wyeth, Otsuko, and Forest Laboratories.

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Authors and Affiliations

  1. Department of Psychiatry, University of North Carolina School of Medicine, Chapel Hill, NC, USA

    Bradley N. Gaynes MD, MPH

  2. University of Texas Southwestern Medical Center at Dallas, Dallas, TX, USA

    A. John Rush MD & Madhukar H. Trivedi MD

  3. Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA

    Stephen R. Wisniewski PhD & G.K. Balasubramani PhD

  4. New York State Psychiatric Institute, New York, NY, USA

    Patrick J. McGrath MD

  5. College of Physicians and Surgeons, Columbia University, New York, NY, USA

    Patrick J. McGrath MD

  6. University of Michigan, Ann Arbor, MI, USA

    Michael Klinkman MD

  7. Massachusetts General Hospital, Boston, MA, USA

    Andrew A. Nierenberg MD & Maurizio Fava MD

  8. University of Oklahoma College of Medicine, Tulsa, OK, USA

    William R. Yates MD

  9. University of Pennsylvania School of Medicine, Philadelphia, PA, USA

    Michael E. Thase MD

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  1. Bradley N. Gaynes MD, MPH
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Correspondence to Bradley N. Gaynes MD, MPH.

Additional information

Trial registry name: Sequenced Treatment Alternatives to Relieve Depression (STAR*D)

Registration identification number: NCT00021528

URL for the registry: http://www.clinicaltrials.gov/ct/show/NCT00021528?order=2

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Gaynes, B.N., Rush, A.J., Trivedi, M.H. et al. Primary Versus Specialty Care Outcomes for Depressed Outpatients Managed with Measurement-Based Care: Results from STAR*D. J GEN INTERN MED 23, 551–560 (2008). https://doi.org/10.1007/s11606-008-0522-3

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