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Clinical Results for Patients With Major Depressive Disorder in the Texas Medication Algorithm Project
Madhukar H. Trivedi, MD;
A. John Rush, MD;
M. Lynn Crismon, PharmD;
T. Michael Kashner, PhD, JD, MPH;
Marcia G. Toprac, PhD;
Thomas J. Carmody, PhD;
Tracie Key, BSN, RN;
Melanie M. Biggs, PhD;
Kathy Shores-Wilson, PhD;
Bradley Witte, BA;
Trisha Suppes, MD, PhD;
Alexander L. Miller, MD;
Kenneth Z. Altshuler, MD;
Steven P. Shon, MD
Arch Gen Psychiatry. 2004;61:669-680.
Context The Texas Medication Algorithm Project is an evaluation of an algorithm-based disease management program for the treatment of the self-declared persistently and seriously mentally ill in the public mental health sector.
Objective To present clinical outcomes for patients with major depressive disorder (MDD) during 12-month algorithm-guided treatment (ALGO) compared with treatment as usual (TAU).
Design Effectiveness, intent-to-treat, prospective trial comparing patient outcomes in clinics offering ALGO with matched clinics offering TAU.
Setting Four ALGO clinics, 6 TAU clinics, and 4 clinics that offer TAU to patients with MDD but provide ALGO for schizophrenia or bipolar disorder.
Patients Male and female outpatients with a clinical diagnosis of MDD (psychotic or nonpsychotic) were divided into ALGO and TAU groups. The ALGO group included patients who required an antidepressant medication change or were starting antidepressant therapy. The TAU group initially met the same criteria, but because medication changes were made less frequently in the TAU group, patients were also recruited if their Brief Psychiatric Rating Scale total score was higher than the median for that clinic's routine quarterly evaluation of each patient.
Main Outcome Measures Primary outcomes included (1) symptoms measured by the 30-item Inventory of Depressive Symptomatology–Clinician-Rated scale (IDS-C30) and (2) function measured by the Mental Health Summary score of the Medical Outcomes Study 12-item Short-Form Health Survey (SF-12) obtained every 3 months. A secondary outcome was the 30-item Inventory of Depressive Symptomatology–Self-Report scale (IDS-SR30).
Results All patients improved during the study (P<.001), but ALGO patients had significantly greater symptom reduction on both the IDS-C30 and IDS-SR30 compared with TAU. ALGO was also associated with significantly greater improvement in the SF-12 mental health score (P = .046) than TAU.
Conclusion The ALGO intervention package during 1 year was superior to TAU for patients with MDD based on clinician-rated and self-reported symptoms and overall mental functioning.
From the Departments of Psychiatry (Drs Trivedi, Rush, Kashner, Biggs, Shores-Wilson, Suppes, and Altshuler, Ms Key, and Mr Witte) and Academic Computing (Dr Carmody), University of Texas Southwestern Medical Center, Dallas; College of Pharmacy, The University of Texas at Austin (Dr Crismon); Health Services Research and Development Service Research Career Scientist Program, Department of Veterans Affairs, Dallas (Dr Kashner); Texas Department of Mental Health and Mental Retardation, Austin (Drs Toprac and Shon); and Department of Psychiatry, University of Texas Health Science Center at San Antonio (Dr Miller). Dr Trivedi is a grantee and/or speaker for Abbott Laboratories, Organon Inc (Akzo), Bayer, Bristol-Meyers Squibb Company, Eli Lilly and Company, GlaxoSmithKline, Janssen Pharmaceutica Products, Johnson & Johnson, National Institutes of Mental Health, Mead Johnson and Company, Parke-Davis, Pfizer Inc, Solvay, Wyeth, NARSAD, and Forest Laboratories Inc. Dr Rush is a grantee, consultant, and/or speaker for the Robert Wood Johnson Foundation, National Institutes of Mental Health, and Stanley Medical Research Institute, Bristol-Myers Squibb Company, Cyberonics Inc, Eli Lilly and Company, Forest Laboratories Inc, GlaxoSmithKline, Organon Inc (Akzo), and Wyeth. Dr Crismon is a grantee, consultant or advisor, and/or speaker for AstraZeneca, Bristol-Meyers Squibb Company, Eli Lilly and Company, Forest Laboratories Inc, and Janssen Pharmaceutica Products, Pharmacia Pharmaceuticals, McNeil Specialty and Consumer Products, and Pfizer Inc. Dr Suppes is a grantee, consultant, and/or speaker or advisor for Abbott Laboraotires, AstraZeneca, Bristol-Meyers Squibb Company, GlaxoSmithKline, Janssen Pharmaceutica Products, National Institutes of Mental Health, Novartis, Robert Wood Johnson Pharmaceutical Research Institute, Stanley Medical Research Institute, Johnson & Johnson Pharmaceutical Research & Development, Pfizer Inc, Pharmaceutical Research Institute, Ortho McNeil Pharmaceutical Inc, UCB Pharma, and Novartis. Dr Miller is a grantee, consultant, and/or speaker for AstraZeneca, Abbott Laboratories, Bristol-Myers Squibb Company, Eli Lilly and Company, Janssen Pharmaceutica Products, and Pfizer Inc.
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