Staging Treatment Intensity and Defining Resistant Depression

Salloum, Naji C.; Papakostas, George I.

doi:10.4088/jcp.18r12250

Cited by 24 publications

(30 citation statements)

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“…Other important aspects that emerged were the difficulties in determining a simple categorical distinction between responses and nonresponses in depression. Following the introduction of the concept of staging in psychiatry in 1993 [12], different methods to stage the degree of treatment resistance in patients with unipolar depression have been suggested [3, 13]. There is no consensus about the superiority of a single staging method.…”

Section: The Development Of the Conceptmentioning

confidence: 99%

“…In the past decade, the number of papers dealing with treatment resistance in depression has increased to a considerable degree. It has recently been discussed whether current definitions of treatment resistance are appropriate: issues of misdiagnosis, diagnostic and biological heterogeneity, and suboptimal therapeutic strategies have been raised [1][2][3]. However, current conceptualizations of treatment resistance focus on the characteristics of the patient (whether neurobiological assets, or attitudes, or psychiatric comorbidity) for the insufficient effectiveness of antidepressant drugs and omit any reference to the potential iatrogenic effects of treatment [4], as if, in the field of infectious disease, treatment resistance were conceptualized independently of the previous use of antibiotics.…”

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confidence: 99%

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The Deceptive Manifestations of Treatment Resistance in Depression: A New Look at the Problem

Fava

Cosci

Guidi

et al. 2020

Psychother Psychosom

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Section: The Development Of the Conceptmentioning

confidence: 99%

mentioning

confidence: 99%

The Deceptive Manifestations of Treatment Resistance in Depression: A New Look at the Problem

Fava

Cosci

Guidi

et al. 2020

Psychother Psychosom

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“…Treatment-resistant depression (TRD) is a widespread term that identifies a clinical condition in which a major depressive disorder (MDD) persists despite antidepressant treatments. Although many medications of different classes have proven to be effective in the treatment of MDD ( Cipriani et al., 2018 ), TRD remains a common clinical scenario, and represents an ongoing clinical challenge ( Rush et al., 2006 ); ( McIntyre et al., 2014 ); ( Salloum and Papakostas, 2019 ); ( McAllister-Williams et al., 2020 ). It is estimated that about one third of MDD patients do not achieve full symptomatic remission, even after multiple antidepressant treatments ( Rush et al., 2006 ).…”

Section: Treatment-resistant Depression: Core Gaps In Knowledgementioning

confidence: 99%

Lost in translation. The quest for definitions of treatment-resistant depression with a focus on inflammation-related gene expression

Sforzini

2021

Brain, Behavior, & Immunity - Health

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Approximately one third of individuals with major depressive disorder (MDD) do not respond to antidepressant treatments; but what does treatment-resistant depression (TRD) mean? With this article, I aim to provide an overview of the clinical and operational criteria currently used to define TRD, highlighting core gaps in knowledge and open questions to be addressed in order to drive future research in the field. Importantly, a better definition of TRD must include a better characterization of the biological and molecular correlates of non-response. Among these potential biomarkers, compelling evidence reveals a potential role of inflammation-related gene expression signatures. A more accurate clinical and etiopathological characterization of TRD subjects may help to identify biologically based MDD clinical phenotypes to be targeted in future research and finally achieve better outcomes.

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“…To make matters worse, all three agents belong to the same pharmacological class of atypical antipsychotics, known to carry a significant side-effect burden [ 5 – 7 ]. While two additional therapies, the olanzapine plus fluoxetine combination and ketamine [ 8 , 9 ], exist for the indication of treatment-resistant depression (TRD) (defined by the U.S. Food and Drug Administration MDD with failure to respond to two or more antidepressant trials [ 10 ]), these are not approved as adjunctive therapy nor studied as second-line treatments. Given the popularity of adjunctive pharmacotherapies in MDD (including second-line) [ 4 ], there is a clear need to further develop effective, safe, and well-tolerated adjunctive medications for this indication.…”

Section: Introductionmentioning

confidence: 99%

Success and efficiency of phase 2/3 adjunctive trials for MDD funded by industry: a systematic review

et al. 2020

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To review the success rate and efficiency of industry-sponsored phase 2/3 clinical trials for adjunctive therapies for antidepressant partial- and non-responders with major depressive disorder (MDD), a systematic search of Pubmed/Medline was conducted, in addition to abstracts of major psychiatric meeting held since 2010, of randomized, placebo-controlled adjunct oral pharmacotherapy trials in this patient population. Forty-six ( n = 33,900; 70 drug compactor arms) trials were pooled, yielding only three approved drugs. Twenty-two (31.4%) drug-placebo comparisons were successful. Numerically, success rates for treatment arms from studies with one versus more than one drug-placebo comparison were higher (39.3% versus 26.2%). The antidepressant lead-in employing single-blind placebo and the sequential-parallel comparison design (SPCD) were successful in 50% and 40% of cases, respectively. The direct randomization (no lead-in) design yielded positive results in one third of cases. The success rate of open-label antidepressant lead-ins without placebo or using double-blind placebo was very poor (<15%). There was also a pronounced discrepancy in terms of efficiency across study designs. Accounting for sample size requirements, a phase 3 program using SPCD would have a higher cumulative chance of yielding two positive trials (50%) than a phase 3 program using a single-blind placebo lead-in (40%). Future programs should carefully weigh the need for a lead-in, which is time-consuming, expensive and, in some cases (i.e., open-label antidepressant without placebo or with double-blind placebo) nearly futile. Instead, more effort should involve the use of studies where patients are directly randomized, such as the SPCD, with more investment shifted towards the accurate and independent vetting of subject eligibility.

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Staging Treatment Intensity and Defining Resistant Depression

Cited by 24 publications

References 0 publications

The Deceptive Manifestations of Treatment Resistance in Depression: A New Look at the Problem

The Deceptive Manifestations of Treatment Resistance in Depression: A New Look at the Problem

Lost in translation. The quest for definitions of treatment-resistant depression with a focus on inflammation-related gene expression

Success and efficiency of phase 2/3 adjunctive trials for MDD funded by industry: a systematic review

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