Prescribing guidelines. The souTh london and Maudsley nhs FoundaTion TrusT oxleas nhs FoundaTion TrusT. 10th edition david Taylor carol Paton shitij Kapur. Pris: kr. E-bok, Laddas ned direkt. Köp Maudsley Prescribing Guidelines in Psychiatry. E-bok (PDF - DRM), Engelska, Ladda ned. Maudsley Prescribing Guidelines Conference To mark the launch of the 11th edition of The Maudsley Prescribing Guidelines.
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C David Taylor, Carol Paton and Shitij Kapur. Published by John Wiley & Sons, Ltd. 2 The Maudsley Prescribing Guidelines in Psychiatry (e.g. Request PDF on ResearchGate | On Jan 1, , D. Taylor and others published Maudsley Prescribing Guidelines in Psychiatry - 11th Edition. Apr , Wiley-Blackwell The lead author of all editions of the Maudsley Prescribing Guidelines, Professor Taylor is the author of several other texts and.
Equally acceptable would be to use a DSM 5 checklist. Andrews G, Jenkins R: Ten-year outcomes in first episode psychotic major depression patients compared with schizophrenia and bipolar patients. J Clin Psychopharmacol. This implies that failure of the first treatment is a meaningful starting point in the measure of this conceptual continuum. Utility of including subsyndromal severity level is demonstrated by the association of this level of depression with disability [ 88 ], poor quality of life [ 89 ] and relapse [ 88 , 90 ].
At the heart of the challenge in defining and staging TRD remains the lack of external validator or biological and physiological marker of depressive disorders and response to treatment. These markers will transform our approaches to staging treatment-resistance. Until then, helpful approaches to staging, including multi-dimensional models are being developed. The initial development of the model was based on extensive literature review, and systematic assessment of the dimensions making the MSM as well as testing of the construct using original data.
The MSM has shown promising predictive validity for both short-term [ 24 — 26 ] and longer-term outcomes [ 27 , 28 ] of TRD. In addition to indications of construct validity based on more elaborate evaluation [ 29 ], the MSM has also been used for screening purposes in clinical trials [ 30 , 31 ] and in studies of determinants of treatment outcomes [ 32 ]. The tool was developed as a loosely structured instrument such that a clinician with mental health training would be able to complete it.
However, we have not published a detailed guidance on how the MSM should be completed. We have received many requests by researchers to provide such guidance to help standardise the completion of the MSM.
The primary aim of this paper is to offer tools for standardisation of the MSM. The paper also provides context by providing an overview of the definitions and staging methods of treatment-resistance in depression and by providing an overview of the main staging methods to date.
The methods were guided by three questions relevant to the objectives of the study: We relied on three complementary approaches to answer these questions. Narrative review was chosen because of the need to focus on high level answers to the questions raised above given the relatively broad nature of the questions asked.
We were also convinced that a broad range of papers of sufficient quality would be obtained through this method. Nevertheless, we borrow some approaches from systematic review methodology to make sure all key works in the field of research are captured and minimise risk of bias. Thus, we searched in Embase, Medline and PsycInfo databases using key terms relevant for treatment resistant depression and staging developed in Pubmed.
The reviewed literature was imported into Endnote software. We begin by describing the definitions and staging of TRD and then provide specific tools for completing or rating the MSM. These tools include measures of the MSM dimensions, illness severity and remission, duration of illness and treatment. We provide a new instrument to collect data on the treatments offered during the course of illness, the Maudsley Treatment Inventory MTI.
A review of 47 treatment trials explored the definitions and staging criteria in TRD [ 37 ]. Lack of consensus was described in both the definition of the depressive syndrome and in how treatment response was operationalised. The required number of antidepressant failure to define treatment non-response was failure of at least one antidepressant medication in about a quarter of studies, while about half required non-response to at least two antidepressant medications [ 37 ].
Treatment non-response was characterized either in terms of failure to achieve a specified percentage reduction in the score of a rating scale or the continuation of a major depressive episode despite treatment.
Most studies defined treatment failure only in relation to the presenting episode while few also included treatment failures, or recurrences whilst on treatment, in previous episodes.
The National Institute of Clinical Excellence NICE defined treatment-resistance in a similar way as failure to respond to two or more sequentially given antidepressant medications [ 41 ]. Unlike the definitions above, the APA definition implies that failure of one medication might be adequate to define treatment-resistance. An adequate trial is defined as 6 weeks of treatment with antidepressant at dosage considered therapeutic.
In the widely used staging method of TRD, the Thase and Rush model [ 44 ], failure to respond to a single adequately given antidepressant medication is implicitly indicated to constitute TRD [ 44 ]. Recent evidence indicates that failure of the first antidepressant treatment may be the gateway towards subsequent treatment failures, especially when the failure was not due to medication intolerance [ 15 ].
However, some participants of the meeting proposed that two failed medications or failure of an eight session psychotherapy would constitute a TRD [ 47 ]. Six staging methods were identified. TRM offers a hierarchical model of staging [ 48 ] in which medications used at the higher order of treatment resistance are implicitly assumed to have superior efficacy. The hierarchical assumptions and limited flexibility to accommodate the potentially numerous medications that may be used to treat a resistant episode are the major drawbacks of the TRM.
The hierarchical model also assumes that medication would be given in a certain sequence, progressing from relatively safe medication to the use of medications with potentially more serious side effects and culminating in the use of electroconvulsive therapy ECT. However, in clinical practice, treatment is prescribed in an individualised way with informed negotiation rather than in a predetermined sequence in which ECT is the treatment of last resort.
Furthermore, in current practice, much more stringent criteria [ 41 , 49 , 50 ] favour the use of ECT in life threatening emergencies. As discussed above, despite some suggestive reports [ 51 ] and the historical assumptions, there is also no robust evidence supporting the superiority of switching to a different antidepressant class as opposed to switching within class [ 15 , 19 , 52 ], as implied in the model. Neither are there clear provisions in the model for combination or augmentation strategies [ 19 ].
In the Massachusetts General Hospital staging method MGH-S [ 19 ], the staging of treatment resistance is mainly based on the number of antidepressant medications used. A special weight is given for failure of treatment with ECT, which receives a score equivalent to three antidepressant failures.
There is some limited evidence on the utility of this model [ 53 ]. The model allows flexibility to incorporate as many failed treatment attempts as required; however, given the potential for a large number of treatment options available currently, the system may be less efficient and less discriminating.
Thus data obtained may not inform intervention strategies or enhance understanding and communication. There is also no clear evidence supporting the magnitude of the special weight given to treatment with ECT. A third method, which is sometimes called the European method of staging relies on matching treatment resistance to specific class of medication used and duration of treatment trials [ 54 ]. The model distinguishes treatment non-response from treatment-resistance.
The former is when there is lack of response to one adequately used antidepressant medication; the latter is applied when two antidepressants fail. The acute subtype of TRD has five hierarchical categories. The model is also limited in scope, and its assumption regarding the differential effectiveness of antidepressant medications does not have clear supporting evidence. A staging model based on depression subtypes on a dimension of severity psychotic, melancholic and non-melancholic [ 56 ] has been shown in a cross-sectional assessment to have convergent validity with clinician impression of resistance [ 56 ].
This model is parsimonious, which also makes it of narrower scope. Given the nature of the severity specifiers, this staging method may tap into bipolarity related treatment failure, which does not always represent true treatment failure. In addition to what has been discussed above, the key shortcoming of these staging models is their reliance on a single criterion, mainly treatment response [ 44 ].
Although failure of antidepressant medication to induce improvement is the sine qua non of treatment-resistance, basing staging methods solely on medication use to the exclusion of other relevant factors such as duration and severity of illness, type of depression and the role of psychosocial stressors has been criticised [ 57 ]. Considering these shortcomings in the available methods, two multi-dimensional scales have been developed [ 24 , 45 ]. Its utility in predicting short- and medium-term outcome was also confirmed [ 24 , 27 , 28 ].
This method was developed from the MSM and extends the MSM by adding items for functional impairment, comorbid anxiety, personality disorders and psychosocial stressors.
Current linear staging models first figure compare with the Maudsley staging method last figure and a more ideal interactive aetiological model middle figure.
The MSM defines treatment-resistance as: Given the role of the failure of the initial treatment as a gateway for treatment-resistance, the MSM uses failure of the first antidepressant treatment to designate the onset of treatment- resistance. Resistance is not an all-or-nothing phenomenon.
It exists as a continuum and various factors dimensions contribute to its occurrence and maintenance. The first and the core dimension is treatment failure. The MSM incorporates severity dimension 2 and duration of the depressive episode dimension 3 as important dimensions to quantify treatment-resistance.
These dimensions are expanded upon below because understanding the assumptions of the MSM are important for understanding and using the proposed rating approaches. Failure of the first treatment appears important in that once the first treatment trial fails, the response rate to each successive treatment declines [ 15 ]. This implies that failure of the first treatment is a meaningful starting point in the measure of this conceptual continuum.
It is proposed that antidepressant treatment should only count if treatment was given for six weeks. However, it can rightly be argued that four weeks could be a useful time frame given the need for early detection of TRD and evidence from earlier treatment trials and indications from guidelines [ 33 , 58 ]. This is reflected in the instrument to assess treatment history, the Maudsley Treatment Inventory MTI Additional file 1 , which also includes rating for a four week treatment trial to aid further research into this question.
Augmentation strategies [ 35 , 59 ] and eight sessions of ECT [ 60 ]are also rated. Failure of treatment is equated with failure to achieve clinical remission. Clinical remission is generally a heterogeneous phenomenon.
The two main questions regarding the definition of remission relate to the threshold of improvement and duration of this improvement that would be required to designate the clinical state as remission. Establishing the threshold of improvement in treatment studies has relied on a serial assessment using depression rating scales, often the HRSD.
The typical consensus based scores that indicate remission, for example score of 7 or less in the HRSD [ 61 ], do not often represent return to complete wellness [ 62 — 66 ]. The level of impairment or difficulty not only depends on the score but also on the type of symptoms that are still unresolved [ 66 ]. Thus, defining clinical remission may require scales, such as the LIFE-chart [ 67 ] that establish remission more explicitly.
However, until more validated methods or scoring systems are developed, using the available rating systems is unavoidable. We do not advocate using functioning as a measure of treatment success for the MSM even though functioning has been advocated as an ideal treatment goal [ 68 ]. Functioning is difficult to measure and is affected by various contextual factors.
More stringent definition, as that within the DSM of two months in remission can be used where sustained remission is the chosen clinical outcome of interest. Inclusion of severity of depression as a staging criterion not only makes clinical sense, but severity of illness has also been consistently associated with non-response in numerous treatment [ 69 — 72 ] and follow-up studies [ 73 — 77 ]. Severity of symptoms is the best predictor of persistence of depressive symptoms [ 78 ] and occurrence of residual symptoms and relapse [ 79 , 80 ].
The association of severity of illness with outcome has been demonstrated for both severity determined by diagnosis according to specified criterion [ 81 , 82 ] or measured by dimensional scales, such as the HRS-D [ 73 ].
Despite some uncertainties as to whether depression with psychotic symptoms may be a distinct disorder [ 84 — 86 ], we have included it as the most severe form of depression as is presented in both ICD and DSM-IV. Utility of including subsyndromal severity level is demonstrated by the association of this level of depression with disability [ 88 ], poor quality of life [ 89 ] and relapse [ 88 , 90 ].
Although it is clear now that the current cut-off points for remission based on standard rating scales, such as the HRSD, do not correlate very well with functional recovery and satisfaction [ 63 , 64 , 66 , 91 ], lower scores may not be pragmatic targets. Adapted from http: Studies have consistently demonstrated that the longer the duration of illness, the poorer the response to treatment in the acute phase of [ 81 , 82 , 92 , 93 ] or augmentation [ 94 ] and predicted shorter relapse free survival [ 79 , 95 ].
We based our model on the duration of the presenting depressive episode, irrespective of treatment experience. We classified duration into three categories.
The recommendations here target research settings where a standardised and replicable assessment is essential. This recommendation would also improve the utility of the MSM in specialist tertiary services, where patients with more complex needs and multiple treatment trials and treatment failures are seen. The tool was also developed with the clinical practitioner in mind.
Clinicians can still continue to complete the MSM relatively quickly using the usual clinical history and benefit from the information for establishing baseline severity of treatment resistance as well as periodic monitoring.
We propose the use of one of three options to rate for treatment failure: The MTI is a novel approach with multiple options for rating medication history. The MTI is described in detail at the end of this section. The system provides operational criteria for adequacy of dosage for each of the most commonly used antidepressants. The strength of the ATRQ is the self-rated nature of the scale, which. On the other hand, the subjective rating may be influenced by mood state of the person rating the instrument.
Higher scores in self-rated scores compared with observer-rated scales may be reflection of personality factors [ 97 ]. Nevertheless, rating medications may be complex for patients and is important to have additional sources of information, such as clinical records, collateral information and other sources.
Is a semi-structured tool that is used to define treatment resistance and treatment history for current and past episodes , including somatic therapies [ 98 — ].
It requires detailed information from different sources about the treatments and, for some medications, has provision for adequacy based on blood levels. The MTI is a semi-structured instrument that we have developed to document psychotropic medications and physical therapies used in the treatment of depression and assist the completion of the MSM. The MTI is more comprehensive and potentially more suitable for rating TRD compared with other schedules developed to document treatment history.
The MTI should be completed using all available information-history from patient and care givers, clinical records as well as other sources, for example, results of structured evaluations. The inventory is primarily designed for use in the current episode, for which treatment resistance is being rated for. However, the MTI may also be used for rating treatment resistance for multiple episodes.
If rating for multiple episodes, multiple MTIs need to be completed. The MTI lists medications available in the UK, but can be modified for use in other countries, by adding the new list of drugs available in the specific setting or modifying the brand names as appropriate. For example, if a person was non-adherent for a substantial period of the follow-up time or was unable to tolerate a medication at an acceptable minimum effective dose, true treatment resistance is unlikely.
For the purposes of the MSM, we recommend using remission as the desired treatment outcome. This rating can be made using an ICD symptom checklist. Equally acceptable would be to use a DSM 5 checklist. However, the common approach in research and tertiary care settings is the use of standard severity rating instruments.
We are aware that the presence of even limited number of symptoms compatible with previous recommendations of remission would be associated with impaired functioning and quality of life [ 62 , 64 , 65 , 91 , , ]. Nevertheless, at present, no concrete research data exists to provide cut-off scores in line with these recent findings.
We have therefore taken the pragmatic approach and restricted our recommendations to what has been well established while awaiting further research. The two key questions regarding duration of the depressive episode are: And what should the period of remission be to separate two apparently distinct episodes into two? In relation to dating onset, we propose provision of separate options for a new episode and relapse episode. For first episode, we propose dating the onset to the time of clear onset of a full episode of illness.
For subsequent episodes, we propose to date the onset to the time when prodromal symptoms of relapse have begun. This distinction is made for the simple pragmatic reason that we know more about the contribution of subthreshold symptoms in relapse and maintenance of depressive episodes.
However, relevance of these propositions has to be tested. The standard duration of remission to separate two episodes is two months. There is no clear reason as to why this duration was chosen, other than the assumption that, in the event of a new episode when the remission has been under two months, may simply be a continuation of the initial illness process rather than emergence of a relapse episode.
There is clear uncertainty regarding duration of remission that heralds the onset of a more sustained remission. Further research in this area is warranted.
Three duration categories are recognised in the MSM. This should include the period prior to the initiation of the treatment. In our research and clinical practice at a tertiary centre, the MSM is completed by research or clinical psychiatrists and trainee psychiatrists. However, the MSM may be rated by a trained research nurse or junior research staff who can complete standard instruments, such as the HRSD.
In research context where multiple users are likely to be involved, inter-rater agreement needs to be established. Agreement on the definition of TRD has remained elusive in four decades.
Nevertheless, treatment resistance is a vexed concept even in other chronic conditions. TRE was defined in less than a third of the studies. When a definition was given, it typically included the number of failed antiepileptic medications tried, and in some cases included the adequacy of dosage, the frequency of seizures and the duration of illness [ ].
In line with this consensus definition for RTE, and evidence that failure of the first antidepressant may be associated with subsequent reduced responsiveness, we have suggested that failure of one treatment should be the threshold for defining TRD.
We thus suggest that failure to respond to the first treatment should count towards defining TRD.
The term refractory implies that virtually all chances of the person responding to treatment are gone. This proposition is contrary to reports of outcome studies, which suggest that, despite chronicity, most patients improve in the longer term with or without treatment [ 27 , — ]. There is no clear evidence to support the occurrence of a similar phenomenon in the treatment of depression.
Treatment-resistance is not an all or none phenomenon but is rather a continuum, and the preferable representation of treatment resistance would be to describe the level of treatment-resistance in terms of various severity grades. Such severity gradation would be useful as the term TRD itself is non-specific and generic. Although remission remains a recommended treatment target, this is not always achievable and should not be a cause for therapeutic nihilism.
Improving symptoms with antidepressants when the severity scores go down to the mild and subthreshold range may be even more challenging and the risk-benefit balance of psychotropic medications more difficult to determine. Systematic follow-up and monitoring of patients without changing or adding medications may be of meaningful benefit to patients with treatment-resistant illness. However, further short- and long-term development work is required.
For example, the definitions of remission, the threshold for TRD and how previous history of non-response to treatment should be incorporated into a staging method is unclear. The potential role of suicidality as severity indicator may need further exploration.
Most importantly, the treatment implication of the MSM should be explored. Matching the staging with recovery goals of patients is another key challenge that requires further work. AF and AJC drafted the paper. All authors contributed to the finalisation of the paper and approved the final submission. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Electronic supplementary material.
Abebaw Fekadu, Email: Jacek G. Donocik, Email: Anthony J. Cleare, Email: National Center for Biotechnology Information , U. BMC Psychiatry. Published online Apr Abebaw Fekadu , 1, 2, 3 Jacek G. Donocik , 3 and Anthony J.
Cleare 3. Author information Article notes Copyright and License information Disclaimer. Corresponding author. Received Nov 30; Accepted Mar This article has been cited by other articles in PMC. Associated Data Supplementary Materials Additional file 1: DOC kb.
Abstract Background Treatment-resistant depression TRD is a serious and relatively common clinical condition. Method Based on the initial development of the MSM and a narrative review of the literature, the developers of the MSM provide explicit guidance on how the three dimensions of the MSM--treatment failure, severity of depressive episode and duration of depressive episode-- may be rated.
Conclusion The approaches provided should have clinical and research utility in staging TRD. Electronic supplementary material The online version of this article Depressive disorder, Treatment-resistant depression, Remission, Staging; Maudsley staging method. Background Treatment-resistance is a common clinical phenomenon in medicine. Methods The methods were guided by three questions relevant to the objectives of the study: Ethical considerations Not applicable.
Definitions Definitions from treatment studies A review of 47 treatment trials explored the definitions and staging criteria in TRD [ 37 ]. Table 1 The main definitions of treatment-resistance in depression. Primarily staging method NICE Failure of 2 antidepressant medication from different classes BAP Failure of 2 antidepressant medication from different classes Refers to commonly used definitions instead of attempting to provide a definition of its own MSM Failure of 1 adequately given antidepressant medication Failure to achieve remission suggested as main outcome criteria; Primarily for staging DM-TRD Failure of 1 adequately given antidepressant medication Based on the MSM Conway et al Failure of 2 adequate dose-duration antidepressants or psychotherapy from different classes Antidepressants given in current episode.
Combinations count individually. Open in a separate window. Current staging methods of TRD Six staging methods were identified. The Maudsley staging method: Considerations in developing the method Definition of treatment-resistance The MSM defines treatment-resistance as: Dimension 1-treatment failure Failure of the first treatment appears important in that once the first treatment trial fails, the response rate to each successive treatment declines [ 15 ].
Severity of depression Inclusion of severity of depression as a staging criterion not only makes clinical sense, but severity of illness has also been consistently associated with non-response in numerous treatment [ 69 — 72 ] and follow-up studies [ 73 — 77 ].
Table 4 Severity ratings compatible with the MSM for commonly used rating scales. Chronicity Studies have consistently demonstrated that the longer the duration of illness, the poorer the response to treatment in the acute phase of [ 81 , 82 , 92 , 93 ] or augmentation [ 94 ] and predicted shorter relapse free survival [ 79 , 95 ].
How to complete rate the MSM: The MSM completion tool The recommendations here target research settings where a standardised and replicable assessment is essential. Rating for treatment failure dimension 1 We propose the use of one of three options to rate for treatment failure: The antidepressant treatment history form ATHF Is a semi-structured tool that is used to define treatment resistance and treatment history for current and past episodes , including somatic therapies [ 98 — ].
The Maudsley treatment inventory MTI The MTI is a semi-structured instrument that we have developed to document psychotropic medications and physical therapies used in the treatment of depression and assist the completion of the MSM. Dimension 2: Dimension 3: Duration of depressive episode The two key questions regarding duration of the depressive episode are: Table 5 Rating for duration of depressive episode.
Who should complete the MSM? Discussion Agreement on the definition of TRD has remained elusive in four decades. Additional file Additional file 1: Funding None for this work.
Availability of data and materials Not applicable. Ethics approval and consent to participate Not applicable.
Evidence-based and written by experts This book is the essential guide for anyone responsible for prescribing, dispensing or administering drugs for patients with mental health disorders. All the evidence has been reviewed and summarized succinctly by an expert team of psychiatrists and pharmacists.
New content and improved format This new edition makes greater use of tables and boxes to facilitate quick reference and includes new sections on cytochrome-mediated interactions and psychiatric side effects of non-psychotropic drugs. Clinically relevant Chapters address plasma monitoring, schizophrenia, bipolar disorder, depression and anxiety, children and adolescents, substance abuse and special patient groups.
Each section has a full reference list.
The book covers prescribing drugs outside their licensed indications and their interaction with substances such as alcohol, nicotine and caffeine. Useful for all levels of experience Trainees will gain important information regarding the rational, safe and effective use of medications for patients with mental illness.
Experienced clinicians will find excellent guidance regarding more complex issues that they may not encounter regularly. Why the Maudsley Prescribing Guidelines in Psychiatry? Long recognized as an international trailblazer in mental health care, the Maudsley Hospital earned its reputation for excellence in both in-patient and community care.
It is highly regarded for its research, and pioneered the use of clinical neuroscience.