The STAR*D Project results: A comprehensive review of findings

Department of Psychiatry, The University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Boulevard, Dallas, TX 75390-9086, USA.
Current Psychiatry Reports (Impact Factor: 3.24). 01/2008; 9(6):449-59. DOI: 10.1007/s11920-007-0061-3
Source: PubMed


The Sequenced Treatment Alternatives to Relieve Depression trial enrolled outpatients with nonpsychotic major depressive disorder treated prospectively in a series of randomized controlled trials. These were conducted in representative primary and psychiatric practices. Remission rates for treatment steps 1 to 4 based on the 16-item Quick Inventory of Depressive Symptomatology-Self-report were 37%, 31%, 14%, and 13%, respectively. There were no differences in remission rates or times to remission among medication switch or among medication augmentation strategies at any treatment level. Participants who required increasing numbers of treatment steps showed greater depressive illness burden and increasingly greater relapse rates in the naturalistic follow-up period (40%-71%). Prognosis was better at all levels for participants who entered follow-up in remission as opposed to those who entered with response without remission. These results highlight the prevalence of treatment-resistant depression and suggest potential benefit for using more vigorous treatments in the earlier steps.

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Available from: Madhukar H Trivedi, Oct 13, 2015
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    • "The STAR*D research program, for example, used an equipoised stratified randomized design and gave each patient the possibility to accept the assignment to a particular treatment strategy (e.g., pharmacotherapy and CBT) or decline it and to move to another study arm. This procedure was intended to be more close to what happens in routine care and to reduce the number of non-consenters, resulting in a higher external validity of the study's findings (Warden et al., 2007). "
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    ABSTRACT: Background: The efficacy of cognitive behavioral therapy (CBT) for the treatment of depressive disorders has been demonstrated in many randomized controlled trials (RCTs). This study investigated whether for CBT similar effects can be expected under routine care conditions when the patients are comparable to those examined in RCTs. Method: N=574 CBT patients from an outpatient clinic were stepwise matched to the patients undergoing CBT in the National Institute of Mental Health Treatment of Depression Collaborative Research Program (TDCRP). First, the exclusion criteria of the RCT were applied to the naturalistic sample of the outpatient clinic. Second, propensity score matching (PSM) was used to adjust the remaining naturalistic sample on the basis of baseline covariate distributions. Matched samples were then compared regarding treatment effects using effect sizes, average treatment effect on the treated (ATT) and recovery rates. Results: CBT in the adjusted naturalistic subsample was as effective as in the RCT. However, treatments lasted significantly longer under routine care conditions. Limitations: The samples included only a limited amount of common predictor variables and stemmed from different countries. There might be additional covariates, which could potentially further improve the matching between the samples. Conclusions: CBT for depression in clinical practice might be equally effective as manual-based treatments in RCTs when they are applied to comparable patients. The fact that similar effects under routine conditions were reached with more sessions, however, points to the potential to optimize treatments in clinical practice with respect to their efficiency.
    Journal of Affective Disorders 09/2015; 189. DOI:10.1016/j.jad.2015.08.072 · 3.38 Impact Factor
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    • "Additionally, non-steroidal anti-inflammatory drugs might be beneficial as adjunctive treatments in unipolar (Akhondzadeh et al., 2009; Muller et al., 2006) and bipolar (Nery et al., 2008) disorders and the TNFα antagonist infliximab may particularly benefit depressed individuals with a history of treatment resistance and high inflammation (Raison et al., 2013). Treatment non-response contributes greatly to the burden of affective illnesses (Gibson et al., 2010); it is common, affecting at least a third of patients (Warden et al., 2007), and is generally associated with poorer long-term outcomes (Fekadu et al., 2009). To improve the rate and robustness of clinical response in depression there is a need for novel treatment strategies (Kupfer et al., 2012), including enhancing the personalisation of treatment provision using stratification . "
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    ABSTRACT: The depressive state has been characterised as one of elevated inflammation, which holds promise for better understanding treatment-resistance in affective disorders as well as for future developments in treatment stratification. Aiming to investigate alterations in the inflammatory profiles of individuals with depression as putative biomarkers for clinical response, we conducted a meta-analyses examining data from 35 studies that investigated inflammation before and after treatment in depressed patients together with a measure of clinical response. There were sufficient data to analyse IL-6, TNFα and CRP. Levels of IL-6 decreased with antidepressant treatment regardless of outcome, whereas persistently elevated TNFα was associated with prospectively determined treatment resistance. Treatment non-responders tended to have higher baseline inflammation, using a composite measure of inflammatory markers. Our findings suggest that elevated levels of inflammation are contributory to treatment resistance. Combining inflammatory biomarkers might prove a useful tool to improve diagnosis and detection of treatment refractoriness, and targeting persistent inflammation in treatment-resistant depression may offer a potential target for the development of novel intervention strategies. Copyright © 2015. Published by Elsevier B.V.
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    • "cokinetic variations exist that impact responses to common psy - chiatric medications ( Burroughs et al . , 2002 ) . An esti - mated two - thirds of patients with depression will not respond adequately to first line treatment and more than one - third of patients will become treatment re - sistant ( Kessler et al . , 2003 ; Souery et al . , 2006 ; Warden et al . , 2007 ) . Genetic variations affect efficacy and tolerability of psychotropics as a result of variable drug disposition , metabolism and transport ( Evans & McLeod , 2003 ; Kao et al . , 2011 ; Porcelli et al . , 2011 ; Salloum et al . , 2014 ) . Many antidepressants and antipsychotics show differences in plasma drug levels as a result of cyt"
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    ABSTRACT: Pharmacogenetic/pharmacogenomic (PGx) testing is currently available for a wide range of health problems including cardiovascular disease, cancer, diabetes, autoimmune disorders, mental health disorders and infectious diseases. PGx contributes important information to the field of precision medicine by clarifying appropriate treatments for specific disease subtypes. Tangible benefits to patients including improved outcomes and reduced total health care costs have been observed. However, PGx-guided therapy faces many barriers to full integration into clinical practice and acceptance by stakeholders, whether practitioner, patient or payer. Each stakeholder has a unique perspective on the role of PGx testing, although all are similarly challenged with demonstrating or appraising its cost-to-benefit value. Coverage by insurers is a critical step in achieving widespread adoption of PGx testing. The acceleration of adoption of precision medicine in general and for PGx testing in particular will be determined by how quickly robust evidence can be accumulated that shows a return on investment for payers in terms of real dollars, for clinicians in terms of patient clinical responses, and for patients in terms of economic, health and quality of life outcomes. Trends in PGx testing utilization and uptake by payers in real-world practice are discussed; the role of pharmacoeconomics in assessing cost-effectiveness is highlighted using a case study in psychiatric care, and several issues that will affect adoption of PGx testing in the United States (US) over the next few years are reviewed.
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