SSRIs and Depression in Children and Adolescents: The Imperative for Shared Decision-Making

Abstract

Objective: In the context of controversy and uncertainty about the role of selective serotonin reuptake inhibitors (SSRIs) for the treatment of depressive disorders in children and adolescents, we consider the evidence of the benefits and risks of this class of medication and the possible role of shared decision-making as a practical way to guide clinicians, young people and their families through treatment decisions.

Conclusion: We suggest that there is an imperative for clinicians to engage young people in a process of shared decision-making, given the uncertainties about SSRI medication in this age group. Shared decision-making provides a way for clinicians to engage young people and ensure they receive the treatment required for this disorder, the potential outcomes of which are severe.

Selective serotonin reuptake inhibitors (SSRIs) are a commonly used treatment for child and adolescent depressive disorders.[1] The recent controversy about suicide-related behaviour and suicidal ideation in young people taking SSRIs (e.g. [2], [3]) is unlikely to have escaped anyone working in the field. This controversy and uncertainty has resulted in declining rates of SSRI use in many countries.[4] An association has been drawn between these declining rates of prescriptions and an observed increase in suicide rates,[4] with many claiming SSRIs are essential for those with depression in this age group (e.g. [5], [6]) although this has been contested.[7], [8] To bring some clarity to the debate about SSRIs for depressive disorders in children and adolescents, the results of a recently published Cochrane systematic review[9] are discussed, with shared decision-making presented as a practical way to ensure engagement of young people in clinical care and judicious prescribing of SSRIs for this population.

EVIDENCE OF THE BENEFITS OF SSRIs

The results of the above mentioned Cochrane systematic review[9] are consistent with other published reviews demonstrating that the only SSRI with consistent evidence of effectiveness in both children and adolescents is fluoxetine. The response rate in the group on fluoxetine ranged between 41% and 61% compared with a range of 20–35% in those on placebo. Consistent with this, depressive symptom scores (CDRS-R) (range 17–113) were statistically significantly lower for those on fluoxetine compared with those on placebo at the end of treatment (treatment effect −5.63 (95% CI −7.38, −3.88).

The limitations and clinical implications of this statistically significant result, however, require examination before drawing conclusions about the findings. With regard to the methodology, it is important to contextualize the results in the knowledge that placebo responders were excluded before randomization to fluoxetine and placebo, that recruitment of participants included media advertising, and that participants with complex comorbidity or who were at risk of suicide were excluded. Therefore, those young people who participated in the trials are not typical of those seen in clinical services.

With regard to the clinical implications, while statistically significant, the size of the difference in improvements in depression severity between the group on fluoxetine and the group on placebo is of questionable importance, equating to 5.63 points on the Children's Depression Rating Scale – Revised (CDRS-R), out of a possible range of 17–113. On this scale, there is a 25-point difference between a clinically referred depressed group and a non-clinical group, and a 19-point difference between clinically referred groups with and without depressive disorders.[10] Remission may be a more clinically meaningful outcome and is more often associated with functional improvement.[11] However, these data were only reported in two trials and only one showed different rates of remission between those on fluoxetine compared with placebo (RR 2.08; CI 1.33, 3.28).[12] The remission rates in the group on fluoxetine ranged between 31% and 41%, and in the placebo group ranged between 20% and 23%. This is consistent with a lack of statistically significant differences in functioning between those on fluoxetine and those on placebo at the end of the trials. As has already been pointed out,[13] one of the major problems we face in treating adolescents with depressive disorder with medication is that the medication is not particularly effective – a point that is often missed in the heated debate about the risk of increased suicidal behaviour of young people on SSRIs.

EVIDENCE OF THE RISKS OF SSRIs

Consistent with other similar reviews,[2], [3] the Cochrane systematic review showed an increased risk of suicide-related outcomes for those on an SSRI compared with placebo (RR 1.80, 95% CI 1.19–2.72). This evidence and the resulting advice from regulatory bodies has seen a reduction in SSRI prescriptions for young people. At the same time, there has apparently been a corresponding increase in suicide rate since 2004.[4] While many have claimed a direct association between the drop in prescription rates and the increase in the suicide rate,[4], [14], [15] there are several alternative explanations. For example, the association may be due to the falling rate of prescriptions of SSRIs, for a subset of young people who may require them e.g. due to greater severity of disorder. Alternatively, the association may be because the recent censure of SSRIs has resulted in pessimism about the availability of effective treatment. This may have caused a reluctance to seek help for depressive disorders. In addition, clinicians may have become disinclined to diagnose depressive disorders due to such questions being raised about medication. A recent study in the USA has shown no increases in psychotherapy referral to compensate for decreasing prescription rates, but also showed a decrease in the number of diagnoses made.[16]

Treatment nihilism has resulted from a failure to turn attention to findings from intervention trials that are cause for optimism. For example, data from the SSRI trials demonstrates that a small group of young people recover when on placebo medication. There is also evidence that some young people respond to simple brief interventions. In the ADAPT trial, 21% of young people who were accepted for the study and met the criteria for moderate to severe depressive disorder responded to ‘standard care’ in the first 2 weeks of the trial, before any adjunctive therapy.[17] Trials such as ADAPT have demonstrated that a high level of ‘standard care’, which may or may not include medication, is sufficient for many,17–19 with response rates after long-term follow-up similar for groups on medication, groups receiving psychotherapy and groups receiving combined interventions.

SHARED DECISION-MAKING

The imperative to engage and treat young people with depressive disorders has been lost in the controversy about SSRIs and the ensuing treatment nihilism. Given the uncertainties about SSRIs, there is an opportunity to use a process of shared decision-making regarding treatment options with young people, which may also facilitate engagement in treatment. Shared decision-making has been advocated in our systematic review,[9] other reviews[20], [21] and guidelines.[22]

Based on tenets from evidence-based medicine and patient-centred care, shared decision-making provides an alternative to both a paternalistic model of care (whereby the doctor makes a decision, only consulting the patient in order to assess symptoms) and an informed choice model of care (whereby the patient makes a decision, only consulting the doctor to obtain information).[23]

Shared decision-making involves knowledge transfer between two parties, namely the healthcare provider, who shares the evidence base for interventions, and the healthcare consumer, who shares their preferences and values about intervention options. This localized and purposeful dissemination of knowledge is central to the process of making a decision about treatment, and facilitates clinical engagement by involving both healthcare providers and healthcare consumers in the decision making process. Healthcare consumers, both in general medical sectors and mental health services, have expressed a desire for more information about treatment options, and also for increased involvement in decisions about treatment (e.g. [24], [25]). Mental health guidelines and policies clearly advocate for the core aspects of shared decision-making.[22] However, this has not necessarily resulted in the implementation of such recommendations. Mental health is one area that has been particularly slow to adopt and action a more consumer-focused model of care, and the implementation of shared decision-making remains a challenge for healthcare providers, consumers and their carers alike. Information about the possible benefits and risks of SSRIs already feature heavily in the public domain, including numerous recent media reports, and therefore explicit discussion within clinical sessions would no doubt be of benefit. Unless clinicians actively address patient concerns, such as any possible aversion to medicines, they are unlikely to be discussed within such sessions.[26]

Shared decision-making facilitates the presentation of the evidence base of treatment options and the elicitation of preferences about these treatment options via decision-making tools called decision aids (for a detailed description see [27]). Decision aids can be presented in a variety of formats (e.g. paper-based, internet-based). They include information about the possible benefits and risks of different treatment options, as well as a section designed to work through the healthcare consumer's preferences and values in relation to the treatment options. Decision aids facilitate a dialogue between the health care provider and health care consumer, allowing for a well informed decision to be made together. If the health care consumer patient does not want to make the final decision, this does not mean that shared decision-making has not occurred. As Edwards and Elwyn have pointed out,[28] the focus should be on the process rather than on who actually makes the decision.

Evidence regarding the demonstrated benefits of decision aids for patients varies according to several factors, including the quality of the decision aid, the outcomes measured, the design of the study and the decision being made. On the whole, however, decision aids serve to: increase patients’ knowledge of treatment options and potential treatment outcomes; clarify patients’ expectations regarding treatment options; increase the concordance between patient preferences and values regarding treatment and the treatment option chosen; increase the patients’ level of participation in the decision-making process; minimize decisional conflict; and minimize the percentage of patients who remain undecided about which treatment option they prefer.[27], [29] Decision aids and shared decision-making have also been associated with increased adherence and patient satisfaction with treatment, although the long-term effects of this need to be further researched (e.g. [30]). Shared decision-making is suitable for when there is no ‘ultimate’ treatment option, and where patient preference is relevant. The investigation of shared decision-making in the area of mental health is therefore warranted.

SHARED DECISION-MAKING IN MENTAL HEALTH

Shared decision-making and decision aids have more recently been incorporated into the mental health field (e.g. [31], [32]), with some initial work in clinical interventions[33] and research trials.[34] Patient preference for a shared decision-making model of care in mental health settings has been demonstrated in a number of qualitative studies,[25] including with inpatients diagnosed with schizophrenia[35] and adult primary care patients with a diagnosis of depression.[36] Clinicians, including general adult psychiatrists, also appear to support a shift toward patient-centred care, endorsing the use of elements of shared decision-making.[37] Further studies analysing clinical sessions have demonstrated, however, that while clinicians may actively ask if patients had any questions, critical aspects of shared decision-making were absent from such sessions, and only very low levels of patient involvement were evident in the decision-making process.[30], [38]

Several trials of shared decision-making have demonstrated its feasibility and utility in increasing effective treatment in mental health. In a study where participants were randomized to decision-making as usual or to shared decision-making, shared decision-making was demonstrated to be a practical intervention that did not require additional time.[39] In a study of primary care provider training, designed to increase guideline-concordant depression treatment (i.e. type of treatment, recommended dosages, number of psychological sessions and so forth), participants who had higher involvement in decision-making were more likely to have received guideline concordant care.[40]

In terms of effectiveness, a large cluster randomized controlled trial in primary care[30] showed improvement in both clinician-rated and self-rated involvement in decision-making, physician ratings of adherence, and patient satisfaction in the shared decision-making group compared with the control group, again without increasing consultation time. A study by the same group found that increased patient participation in treatment decision-making was associated with increased adherence to the chosen treatment option,[41] demonstrating the potential for shared decision-making to result in good clinical outcomes.

While the findings are promising, further research is required to understand the effect of shared decision-making on clinical outcomes and, more particularly, the feasibility and utility of shared decision-making for adolescents who have a mental health disorder, such as depression. Shared decision-making with young people has not yet been formally investigated, and may be somewhat different to shared decision-making with adults. There may need to be modification of the shared decision-making process given the developmental stage and the possibility of family involvement in treatment decisions. The limited evidence available for the efficacy of SSRI medication, and the possible associated risks for children and adolescents, means there is a compelling reason to undertake shared decision-making for this group. It provides a way to navigate a path through treatment decisions, that, in the current context of controversy and uncertainty, are difficult, and it has the potential to encourage guideline-concordant antidepressant prescribing. Perhaps more importantly, shared decision-making can act as a tool of engagement ensuring young people receive the best clinical care.

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