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Gaynes BN, Asher G, Gartlehner G, et al. Definition of Treatment-Resistant Depression in the Medicare Population [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2018 Feb 9.
Definition of Treatment-Resistant Depression in the Medicare Population [Internet].
Show detailsTable 6Definitions Of Treatment-Resistant Depression And Level Of Consensus By Number Of Treatment Failures: Guidelines And Consensus Statements As Source
| Number of Treatment Failures as a Consensus | Focus of Guideline or Consensus Statement, Author, Date | Definition of Treatment-Resistant Depression | Define Failure | Current Episode? | Define Adequate Dose? | Define Adequate Duration? | Consensus? | Specifically Stated or Most Frequently Used Definition? |
|---|---|---|---|---|---|---|---|---|
| 1 or more | International Workshop on “Present and Future of TMS: Safety and Ethical Guideline” Rossi et al., 200968 | Patients with medication-refractory unipolar depression who failed one good (but not more than one) pharmacological trial | Not found | Not found | Not found | Not found | Yes | Report is from a consensus conference for TRD about when rTMS should be offered |
| 2 or more | World Federation of Societies of Biological Psychiatry Guidelines for Unipolar Depression Bauer et al., 200967 | Patients who remain depressed and do not achieve adequate relief and a satisfactory level of functioning even after two or more adequate courses of treatment. Having failed to improve after two adequately performed trials of AD drug; these no-responders are considered “treatment resistant.” | Patient is not showing any improvement after 4 weeks of treatment with an AD drug at an appropriate dose | Not found | Not found | At least 6 weeks, and 8 to 10 weeks | No | Reports the most commonly used definition. Notes that there is no clear consensus which strategy should be favored for the non-responding patient since to date no rigorous trial with a randomized, double-blind design has been conducted to answer this question. |
| Unipolar Depression Guideline Harter et al., 201070 | In therapy-resistant depression (where pharmacotherapy has been administered adequately, with at least two drugs, one after the other, at a sufficiently high dosage and given for a long enough time interval), patients should be offered appropriate psychotherapy | Not found | Not found | Not found | Not found | Yes | Proposed a definition for when psychotherapy should be offered | |
| Institute for Clinical and Economic Review ICER) Coverage Policy Analysis, 201238 | Notes that definitions of so-called “treatment-resistant” depression vary; this generally refers to patients with persistent depression after attempted management with two or more medications | Failure to evoke a clinically significant and lasting response | Not found | Not found | Not found | No | Reports the most commonly used definition | |
| Report from European Medicines Agency consensus meeting in 2009—Improving outcomes in TRD Schlaepfer et al., 201269 | CHMP has stated that a patient is considered to be therapy resistant when consecutive treatment with two antidepressants of different classes (different mechanism of action), used for a sufficient length of time and at an adequate dose, fail to induce an acceptable effect. CHMP also notes that the definition of TRD itself is not always consistent between studies or treatment guidelines, and a clear definition would go some way to refining treatment options. | Not found | Not found | Not defined and consensus from the wider psychiatric community is still required | Not defined and consensus from the wider psychiatric community is still required | Yes | Cites the CHMP (EMA) definition. Some staging models have been used to define TRD, but further clinical validation is needed. In addition, true pharmacological resistance needs to be distinguished from resistance attributable to ongoing somatic or psychosocial problems | |
| British Association for Psycho-pharmacology Guidelines for all depressive orders, revision based on 2012 consensus meeting Cleare et al., 201579 | Most describe it as a failure to respond to two or more adequate AD treatment trials | Lack of improvement (defined as at least a 20% to 30% reduction in HAM-D in different studies) at 4 and 6 weeks; only 20% and 10%, respectively, will go on to eventual response (≥50% improvement) at 8 weeks | Important to consider the current episode in the context of the overall history of depression and the nature of previous episodes when considering treatment options | Adequate treatment, defined as “recommend ed therapeutic dose” | 4–8 weeks | No | Reports the most commonly used definition. Notes that problems arise in defining what comprises an adequate treatment trial, which drugs are to be included and in taking account of psychological treatments. | |
| VA/DoD Clinical Practice Guidelines for Management of MDD, 201623 | Lack of full response despite at least two adequate treatment trials | Lack of full response to an adequate treatment trial | Not found | Not found | Not found | Yes | Guideline says there is consensus | |
| CANMAT Guidelines, 2016 Kennedy et al., 201674 Pharmacological treatments Psychological treatments Parikh et al., 201675 Neuro-stimulation treatments Milevet al., 201676 CAM treatments Ravindran et al., 201677 Special populations: youth, women, and the elderly MacQueen et al., 201678 | Notes that the most commonly employed definition is inadequate response to 2 or more AD drugs | Inadequate response (e.g., 25%-49% reduction in symptom scores) or no response (e.g., <25% reduction) | Not found | Not found | Not found | No | Reports the most commonly used definition Notes that the commonly applied definition does not take into account adjunctive strategies and does not differentiate between patients who have had partial response versus those who have had no response | |
| 2 or more (MDD: ≥2; Bipolar I: ≥2 [specific treatments specified], Bipolar II: ≥2 [specific treatments specified]) | Australian and New Zealand clinical practice guidelines for mood disorders Malhiet al., 201542 | MDD: Lack of improvement following adequate trials of two or more ADs Bipolar I depression: Failure to reach remission with adequately dosed lithium or to other adequate ongoing mood-stabilizing treatment, plus lamotrigine or with full-dose quetiapine as monotherapy Bipolar II depression: Failure to reach remission with adequately dosed lithium or other adequate ongoing mood-stabilizing treatment, plus lamotrigine or with full-dose quetiapine as monotherapy | Failure to reach remission with adequate dose | Not found | Not found | 6 weeks of treatment | Ye | Provides several definitions depending on the underlying mood disorder |
| 3 or more, 3 different classes | ICSI, Guidelines for adult depression in primary care Trangle et al., 201621 | Defines true treatment resistance Failure to as failure to achieve remission achieve with an adequate trial of therapy remission and three different classes of AD drugs at adequate duration and dosage | Failure to achieve remission | Not found | Not found | Not found | No | Identifies a definition for primary care clinicians “True treatment resistance is seen as occurring on a continuum, from failure to reach remission after an adequate trial of a single [AD drug] to failure to achieve remission despite several trials of [AD drugs] augmentation strategies, ECT and psychotherapy.” |
| Did not specifically address | American Psychiatric Association guideline for the treatment of MDD Gelenberg et al., 201019 | Frequently uses the term “treatment-resistant” but never defines it; refers to “next steps” in treatment | Not found | For rTMS, FDA says individuals with MDD who have not had a satisfactory response to at least one AD trial in the current episode of illness | Not found | Not addressed for TRD; generally, adequate treatment with an AD medication for at least 4–6 weeks For psychotherapy, a few months | No | Not found |
| NICE Depression Guidance, 200971 NICE VNS Guidance, 200973 NICE rTMS Guidance 201571 Various guidelines concerning depression, use of vagal nerve stimulation, and use of rTMS | Did not define Earlier NICE guidelines had referred to TRD defined as depression that had not responded adequately to two courses of AD drugs (of adequate dose and length) The current guideline groups preferred to approach the problem of inadequate response by considering sequenced treatment options rather than by a category of patient | Does not clearly define; refers to Inadequate response, which could reflect both lack of response and lack of remission, and considers both patient and clinician perspectives | Not found | Not found | Not found | No. NICE eschews use of the term “treatment-resistant depression” | Previous versions of the guidelines stated that the most commonly used definition was nonresponse to two or more adequate trials of ADs. Due to this definition not including psychotherapeutic treatment, non-antidepressant augmenting agents and psychosocial factors, the new guidelines use a sequence of treatment options rather than number of failures. | |
| Unipolar depression Ontario Health Association, 201664 | Considers stages of treatment resistance (e.g., Stage 1 indicates failure to achieve response after one course of adequate treatment; Stage 2 indicates failure to achieve response after two courses of adequate treatment) | Cannot achieve remission | Cites FDA definition for rTMS: Treatment of adult patients with unipolar depression whose current episode did not respond to one adequate dose of AD medication | Not found | Long enough to take effect, at least 2 weeks or 10 sessions | No | Does not identify the most commonly used definition Notes that definition of adequate response ranges from failure to achieve response to failure to achieve full symptom remission and that most experts agree that inadequate response is the failure to achieve full symptom remission |
AD = antidepressant; CAM = complementary and alternative medicine; CANMAT = Canadian Network for Mood and Anxiety Treatments; CHMP = Committee for Medicinal Products for Human Use; ECT = electroconvulsive therapy; EMA = European Medicines Agency; FDA = Food and Drug Administration; HAM-D = Hamilton Depression Rating Scale; ICER = Institute for Clinical and Economic Review; ICSI = Institute for Clinical Systems Improvement; MDD = major depressive disorder; NICE = National Institute for Health and Clinical Excellence; rTMS = repetitive transcranial magnetic stimulation; TMS = transcranial magnetic stimulation; TRD = treatment-resistant depression; VA/DoD = Department of Veterans Affairs and Department of Defense; VNS = vagus nerve stimulation.
- Table 6, Definitions Of Treatment-Resistant Depression And Level Of Consensus By...Table 6, Definitions Of Treatment-Resistant Depression And Level Of Consensus By Number Of Treatment Failures: Guidelines And Consensus Statements As Source - Definition of Treatment-Resistant Depression in the Medicare Population
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