TY - JOUR
T1 - Sequenced treatment alternatives to relieve depression (STAR*D)
T2 - Rationale and design
AU - Rush, A. John
AU - Fava, Maurizio
AU - Wisniewski, Stephen R.
AU - Lavori, Philip W.
AU - Trivedi, Madhukar H.
AU - Sackeim, Harold A.
AU - Thase, Michael E.
AU - Nierenberg, Andrew A.
AU - Quitkin, Frederic M.
AU - Kashner, T. Michael
AU - Kupfer, David J.
AU - Rosenbaum, Jerrold F.
AU - Alpert, Jonathan
AU - Stewart, Jonathan W.
AU - McGrath, Patrick J.
AU - Biggs, Melanie M.
AU - Shores-Wilson, Kathy
AU - Lebowitz, Barry D.
AU - Ritz, Louise
AU - Niederehe, George
N1 - Funding Information:
This project has been funded in part with federal funds from the National Institute of Health, National Institute of Mental Health under Contract N01-MH-90003. Additional funds were provided by the Betty Jo Hay Distinguished Chair in Mental Health, Rosewood Corporation Chair in Biomedical Science and the Sara M. and Charles E. Seay Center for Basic and Applied Research in Psychiatry (A.J.R.), and by MH-30915 (Mental Health Intervention Research Center) (M.E.T., D.J.K.). The following pharmaceutical companies are providing medication for STAR*D participants: Bristol-Myers Squibb, Forest Laboratories, GlaxoSmithKline, King Pharma, Novartis, Organon, Pfizer, and Wyeth-Ayerst. The authors appreciate the contributions of the NIMH STAR*D Scientific Advisory Group, the NIMH Protocol Oversight Committee, the thoughtful consultation by Health Technology Systems, Inc., and the guidance of the NIMH Data and Safety Monitoring Board. We appreciate the provision of educational materials by the Texas Department of Mental Health and Mental Retardation. The authors appreciate the secretarial support of Fast Word Information Processing Inc. (Dallas, Texas) and David Savage, and the administrative support of Kenneth Z. Altshuler, M.D., Stanton Sharp Distinguished Chair (past Chairman) and Eric Nestler, M.D., Ph.D., Lou and Ellen McGinley Distinguished Professor and Chairman, Department of Psychiatry, University of Texas Southwestern Medical Center. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government.
PY - 2004/2
Y1 - 2004/2
N2 - STAR*D is a multisite, prospective, randomized, multistep clinical trial of outpatients with nonpsychotic major depressive disorder. The study compares various treatment options for those who do not attain a satisfactory response with citalopram, a selective serotonin reuptake inhibitor antidepressant. The study enrolls 4000 adults (ages 18-75) from both primary and specialty care practices who have not had either a prior inadequate response or clear-cut intolerance to a robust trial of protocol treatments during the current major depressive episode. After receiving citalopram (level 1), participants without sufficient symptomatic benefit are eligible for randomization to level 2 treatments, which entail four switch options (sertraline, bupropion, venlafaxine, cognitive therapy) and three citalopram augment options (bupropion, buspirone, cognitive therapy). Those who receive cognitive therapy (switch or augment options) at level 2 without sufficient improvement are eligible for randomization to one of two level 2A switch options (venlafaxine or bupropion). Level 2 and 2A participants without sufficient improvement are eligible for random assignment to two switch options (mirtazapine or nortriptyline) and to two augment options (lithium or thyroid hormone) added to the primary antidepressant (citalopram, bupropion, sertraline, or venlafaxine) (level 3). Those without sufficient improvement at level 3 are eligible for level 4 random assignment to one of two switch options (tranylcypromine or the combination of mirtazapine and venlafaxine). The primary outcome is the clinician-rated, 17-item Hamilton Rating Scale for Depression, administered at entry and exit from each treatment level through telephone interviews by assessors masked to treatment assignments. Secondary outcomes include self-reported depressive symptoms, physical and mental function, side-effect burden, client satisfaction, and health care utilization and cost. Participants with an adequate symptomatic response may enter the 12-month naturalistic follow-up phase with brief monthly and more complete quarterly assessments.
AB - STAR*D is a multisite, prospective, randomized, multistep clinical trial of outpatients with nonpsychotic major depressive disorder. The study compares various treatment options for those who do not attain a satisfactory response with citalopram, a selective serotonin reuptake inhibitor antidepressant. The study enrolls 4000 adults (ages 18-75) from both primary and specialty care practices who have not had either a prior inadequate response or clear-cut intolerance to a robust trial of protocol treatments during the current major depressive episode. After receiving citalopram (level 1), participants without sufficient symptomatic benefit are eligible for randomization to level 2 treatments, which entail four switch options (sertraline, bupropion, venlafaxine, cognitive therapy) and three citalopram augment options (bupropion, buspirone, cognitive therapy). Those who receive cognitive therapy (switch or augment options) at level 2 without sufficient improvement are eligible for randomization to one of two level 2A switch options (venlafaxine or bupropion). Level 2 and 2A participants without sufficient improvement are eligible for random assignment to two switch options (mirtazapine or nortriptyline) and to two augment options (lithium or thyroid hormone) added to the primary antidepressant (citalopram, bupropion, sertraline, or venlafaxine) (level 3). Those without sufficient improvement at level 3 are eligible for level 4 random assignment to one of two switch options (tranylcypromine or the combination of mirtazapine and venlafaxine). The primary outcome is the clinician-rated, 17-item Hamilton Rating Scale for Depression, administered at entry and exit from each treatment level through telephone interviews by assessors masked to treatment assignments. Secondary outcomes include self-reported depressive symptoms, physical and mental function, side-effect burden, client satisfaction, and health care utilization and cost. Participants with an adequate symptomatic response may enter the 12-month naturalistic follow-up phase with brief monthly and more complete quarterly assessments.
KW - Antidepressants
KW - Cognitive therapy
KW - Major depressive disorder
KW - Multistep multicenter clinical trial
KW - Randomized clinical trial
KW - Utilization and costs
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U2 - 10.1016/S0197-2456(03)00112-0
DO - 10.1016/S0197-2456(03)00112-0
M3 - Article
C2 - 15061154
AN - SCOPUS:10744220820
SN - 0197-2456
VL - 25
SP - 119
EP - 142
JO - Controlled Clinical Trials
JF - Controlled Clinical Trials
IS - 1
ER -