Abstract
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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 119-142 |
| Number of pages | 24 |
| Journal | Controlled Clinical Trials |
| Volume | 25 |
| Issue number | 1 |
| DOIs | |
| State | Published - Feb 2004 |
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Keywords
- Antidepressants
- Cognitive therapy
- Major depressive disorder
- Multistep multicenter clinical trial
- Randomized clinical trial
- Utilization and costs
ASJC Scopus subject areas
- Pharmacology
Cite this
Sequenced treatment alternatives to relieve depression (STAR*D) : Rationale and design. / Rush, A. John; Fava, Maurizio; Wisniewski, Stephen R.; Lavori, Philip W.; Trivedi, Madhukar H.; Sackeim, Harold A.; Thase, Michael E.; Nierenberg, Andrew A.; Quitkin, Frederic M.; Kashner, T. Michael; Kupfer, David J.; Rosenbaum, Jerrold F.; Alpert, Jonathan; Stewart, Jonathan W.; McGrath, Patrick J.; Biggs, Melanie M.; Shores-Wilson, Kathy; Lebowitz, Barry D.; Ritz, Louise; Niederehe, George.
In: Controlled Clinical Trials, Vol. 25, No. 1, 02.2004, p. 119-142.Research output: Contribution to journal › Article
}
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
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
UR - http://www.scopus.com/inward/record.url?scp=10744220820&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=10744220820&partnerID=8YFLogxK
U2 - 10.1016/S0197-2456(03)00112-0
DO - 10.1016/S0197-2456(03)00112-0
M3 - Article
C2 - 15061154
AN - SCOPUS:10744220820
VL - 25
SP - 119
EP - 142
JO - Controlled Clinical Trials
JF - Controlled Clinical Trials
SN - 0197-2456
IS - 1
ER -