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.; Sackeïm, Harold A.; Thase, Michael E.; Nierenberg, Andrew A.; Quitkin, Frederic M.; Kashner, T. Michael; Kupfer, David J.; Rosenbaum, Jerrold F.; Alpert, Jonathan E.; Stewart, Jonathan W.; McGrath, Patrick J.; Biggs, Melanie M.; Shores-Wilson, Kathy; Lebowitz, Barry D.; Ritz, Louise; Niederehe, George

doi:10.1016/s0197-2456(03)00112-0

Cited by 920 publications

(777 citation statements)

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“…Thirteen articles, representing six unique studies, were included in the final review and are described in detail under Appendix B (available online). 20,23,[27][28][29][30][31][32][33][34][35][36][37] One of the studies-the STAR*D trial-examined psychotherapy in separate treatment arms as either an augmentation or substitution treatment. Because each employed a unique comparison group, these two arms were treated as separate studies in this review.…”

Section: Resultsmentioning

confidence: 99%

“…[16][17][18][19] MDD patients who do not fully remit after initial ("Step 1") treatment are thought to have treatment resistant depression, defined as an inadequate response to at least one trial of an antidepressant, at an adequate dose, for 6 weeks or longer. 20 According to guidelines, treatment resistant depression may be treated with four Step 2 strategies: augmenting current regimens with another antidepressant, substituting current regimens with another antidepressant, augmenting treatment through adding psychotherapy, or substituting psychotherapy for antidepressant medications. [21][22][23] However, studies have shown that it is more common to consider medication changes than to consider psychotherapy.…”

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Examination of the Utility of Psychotherapy for Patients with Treatment Resistant Depression: A Systematic Review

2010

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Section: Resultsmentioning

confidence: 99%

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Examination of the Utility of Psychotherapy for Patients with Treatment Resistant Depression: A Systematic Review

2010

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“…Remission of major depression is difficult to achieve for many patients and less than 50% of depressed patients will respond to standard treatments (Hirchfield et al, 2002;Keitner et al, 2006;Rush et al, 2004;Trivedi et al, 2006). Several treatment strategies are available for depressed patients who fail to respond, or only partially respond, to an adequate trial of antidepressant monotherapy but the next step after a failed adequate medication trial remains unclear (Keller, 2005;Nelson, 2003).…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, rapid recovery of severe depression is the exception rather than the rule (Lewis, 2003). In the STAR*D project only 28% of patients remitted and less than 50% responded to the first antidepressant mono-therapy trial (Rush et al, 2004;Trivedi et al, 2006). Depressed patients who do not respond to adequate antidepressant treatment pose a clinical dilemma.…”

Section: Introductionmentioning

confidence: 99%

A randomized, placebo-controlled trial of risperidone augmentation for patients with difficult-to-treat unipolar, non-psychotic major depression

Keitner

Garlow

Ryan

et al. 2009

Journal of Psychiatric Research

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Objective-Patients (30-50%) with non-psychotic major depression will not respond despite an adequate trial of antidepressant medication. This study evaluated risperidone as an augmenting agent for patients who failed or only partially responded to an adequate trial of an antidepressant medication.Method-Ninety-seven patients with unipolar non-psychotic major depression who were not responsive to antidepressant monotherapy were randomized to risperidone (0.5-3 mg/day) or placebo augmentation in a four-week, double-blind, placebo controlled treatment trial. The primary outcome measure was remission defined by a score of ≤10 on the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary outcomes measures were the Hamilton Rating Scale for Depression, the Clinician Global Impression of Severity scale and the overall satisfaction item of the Quality of Life and Enjoyment Questionnaire.Results-Subjects in both treatment groups improved significantly over time. The odds of remitting were significantly better for patients in the risperidone vs. placebo arm (OR = 3.33, p = . 011). At the end of 4 weeks of treatment 52% of the risperidone augmentation group remitted (MADRS ≤ 10) compared to 24% of the placebo augmentation group (CMH(1) = 6.48, p = .011), but the two groups were converging. Patients in the risperidone group also reported significantly more improvement in quality-of-life than patients in the placebo group. There were no betweengroup differences in the number of adverse events reported, however, weight gain was significantly higher in the group receiving risperidone. Conclusion-Augmentation of an antidepressant with risperidone for patients with difficult-totreat depression leads to more rapid response and a higher remission rate and better quality-of-life.

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“…Technological advances in human genetics over the past decade, along with the availability of large treatment cohorts for study, such as in the Sequenced Treatment Alternatives to Relieve Depression (STAR * D) (6), promise to transform pharmacogenetics into one of the foundations of evidence-based medicine. This article reviews the implications of STAR * D findings for pharmacogenetics research.…”

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Pharmacogenetics Studies in STAR*D: Strengths, Limitations, and Results

Laje

Perlis²,

Rush³

et al. 2009

Psychiatric Services

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Several lines of evidence support an important genetic contribution to the wide individual variation in therapeutic response to antidepressant medications. The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study provided the largest cohort assembled to date of DNA from patients with nonpsychotic major depressive disorder, uniformly treated with citalopram and followed prospectively for up to 12 weeks. This pivotal study changed the face of pharmacogenetics research by increasing the sample size by an order of magnitude as well as by providing detailed prospective information about antidepressant response and tolerability. Several groups have identified markers in genes and tested the replication of previous findings of genes associated with outcome and side effects of antidepressant treatment. Variants in HTR2A, GRIK4, and KCNK2 were associated with citalopram treatment outcome. Replication was achieved in markers in the FKBP5 gene. Other findings in PDE11A and BDNF were not successfully replicated, and reports of potential confounders in previous associations with serotonin transporter variation (SLC6A4) were identified. Polymorphisms in pharmacokinetic genes involved in metabolism and transmembrane transport were also not associated with antidepressant response. Adverse events were also tested. Treatment-emergent suicidal ideation was associated with GRIK2, GRIA3, PAPLN, IL28RA, and CREB1. Sexual dysfunction was linked with variation in GRIN3A, GRIA1 GRIA3, and GRIK2. Reported and future findings of pharmacogenetics studies in STAR*D could help elucidate pathways involved in major depression and those pertinent to antidepressant outcome and side effects. Replication of these findings in independent samples could lead to the development of new treatments and to optimization of available treatments.

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Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design

Cited by 920 publications

References 48 publications

Examination of the Utility of Psychotherapy for Patients with Treatment Resistant Depression: A Systematic Review

Examination of the Utility of Psychotherapy for Patients with Treatment Resistant Depression: A Systematic Review

A randomized, placebo-controlled trial of risperidone augmentation for patients with difficult-to-treat unipolar, non-psychotic major depression

Pharmacogenetics Studies in STAR*D: Strengths, Limitations, and Results

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