The goal of this article is to shed light on Deep Brain Stimulation (DBS) postoperative suicidality risk factors within Treatment Resistant Depression (TRD) patients, in particular by focusing on the ethical concern of enrolling patient with history of self-estrangement, suicide attempts and impulsive–aggressive inclinations. In order to illustrate these ethical issues we report and review a clinical case associated with postoperative feelings of self-estrangement, self-harm behaviours and suicide attempt leading to the removal of DBS devices. Could prospectively (...) identifying and excluding patients with suicidality risk factors from DBS experimental trials—such as history of self-estrangement, suicide attempts and impulsive–aggressive inclinations—lead to minimizing the risk of suicidality harm? (shrink)

Deep brain stimulation is an experimental procedure for treatment-resistant depression. Some results show promise, but blinded trials had limited success. Ethical questions center on vulnerability: especially on whether depressed patients can weigh the risks and benefits effectively, whether depression causes “desperation,” and whether media portrayals create unrealistic hopes. We interviewed 24 psychiatric inpatients with treatment-resistant depression, qualitatively analyzing their comments. Most had minimal interest in deep brain stimulators. Some might consider them if their (...) depression worsened, if alternatives were exhausted, or if the evidence were stronger. Fears focused on the surgery, adverse effects, and the novelty of the device. Patients felt the depression interfered with their ability to weigh the risks and benefits. Patients seemed highly attuned to the risks, and were skeptical that the treatment would be effective. We conclude that ethical concerns about vulnerability remain, yet patients with treatment-resistant depression were thoughtful and cautious about trying a novel therapy. (shrink)

Since the Nuremberg trials (1947–1949), informed consent has become central for ethical practice in patient care and biomedical research. Codes of ethics emanating from the Nuremberg Code (1947) recognize the importance of protecting patients and research subjects from abuses, manipulation and deception. Informed consent empowers individuals to autonomously and voluntarily accept or reject participation in either clinical treatment or research. In some cases, however, the underlying mental or physical condition of the individual may alter his or her cognitive abilities (...) and compromise the informed consent process. This is particularly true in chronic psychiatric conditions such as Treatment-Resistant Depression (TRD), where individuals may fail to respond to traditional antidepressant treatments (e.g., psychotherapy, pharmacotherapy). Moreover, it may raise further concerns for an individual’s motivation to consent and the level of understanding of the treatment or research procedure. This paper focuses on the informed consent process for Vagus Nerve Stimulation (VNS) in the treatment of individuals diagnosed with TRD. Specifically, the paper addresses how depression may affect the decision-making capacity of an individual and the potential ethical and legal impact of failure to appreciate the seven elements of the consenting process (competence, voluntariness, disclosure, recommendation, understanding, decision, and authorization). To ensure the protection of vulnerable individuals with psychiatric disorders such as TRD and promote ethical behavior in biomedical research and patient care while avoiding potential legal pitfalls, we propose a paradigm that requires a stringent evaluation process of decision-making capacity for informed consent. (shrink)

Treatment-resistant depression (TRD) holds centrality in many debates regarding psychiatric euthanasia. Among the strongest reasons cited by opponents of psychiatric euthanasia is the uncertainty behind the irremediability of psychiatric illnesses. According to this argument, conditions that cannot be considered irremediable imply that there are possible remedies that remain for the condition. If there are possible remedies that remain for the condition, then patients with that condition cannot be considered for access to euthanasia. I call this the irremediability (...) requirement (IR). I argue that patients with TRD can, indeed, meet the operationalisation of irremediability in the IR. This is because the irremediability it asks for is not some global or absolute irremediability, but rather a present irremediability based on the current state of medical science. I show this by considering irremediability relating to (1) possible future treatments and (2) not trying presently available alternative treatments. I extend Schuklenk nd van de Vathorst’s argument from parity to terminal malignancies, to show that (1) is an unreasonable expectation for all cases of euthanasia. Taking (2) as a more serious opponent to psychiatric euthanasia, I show how the IR, based on how it is presently operationalised, can be realistically applied to cases of TRD. I do this by further developing Tully’s argument on broad-sense treatment resistance with the robust empirical data from the STAR*D trials. If my argument from Tully’s is valid, then we have reasons to, again, seek parity between the operationalisations of irremediability in terminal malignancies and TRD. (shrink)

The introduction of new medical treatments based on invasive technologies has often been surrounded by both hopes and fears. Hope, since a new intervention can create new opportunities either in terms of providing a cure for the disease or impairment at hand; or as alleviation of symptoms. Fear, since an invasive treatment involving implanting a medical device can result in unknown complications such as hardware failure and undesirable medical consequences. However, hopes and fears may also arise due to the (...) cultural embeddedness of technology, where a therapy due to ethical, social, political and religious concerns could be perceived as either a blessing or a threat. While Deep Brain Stimulation (DBS) for treatment resistant depression (TRD) is still in its cradle, it is important to be proactive and try to scrutinize both surfacing hopes and fears. Patients will not benefit if a promising treatment is banned or avoided due to unfounded fears, nor will they benefit if DBS is used without scrutinizing the arguments which call for caution. Hence blind optimism is equally troublesome. We suggest that specificity, both in terms of a detailed account of relevant scientific concerns as well as ethical considerations, could be a way to analyse expressed concerns regarding DBS for TRD. This approach is particularly fruitful when applied to hopes and fears evoked by DBS for TRD, since it can reveal if our comprehension of DBS for TRD suffer from various biases which may remain unnoticed at first glance. We suggest that such biases exist, albeit a further analysis is needed to explore this issue in full. (shrink)

Should people suffering from untreatable psychiatric conditions be eligible for physician-assisted death? This is possible in Belgium and the Netherlands, where PAD for psychiatric conditions is permitted, though rare, so long as the criteria of due care are met. Those opposed to all instances of PAD point to Belgium and the Netherlands as a dark warning that once PAD is legalized, restricting it will prove impossible because safeguards, such as the requirement that a patient be terminally ill, will inevitably be (...) eroded or discarded. However, some supporters respond that limiting PAD to those suffering from terminal illness, or physical illnesses generally, is arbitrary and illogical. In addition, precisely because such patients are not terminally ill, their suffering may last for years, even the rest of their lives. Finally, severe depression may not be treatable. If PAD is justifiable under some conditions—as I shall assume in this article—then why wouldn't it be justifiable for these patients? Why shouldn't psychiatrists who have nothing else to offer their suffering patients be able to help them to die, if that is what they want? (shrink)

The adaptive BCI known as ‘closed-loop deep brain stimulation’ (clDBS) is a device that stimulates the brain in order to prevent pathological neural activity and automatically adjusts stimulation levels based on computational algorithms that detect or predict those pathological processes. One of the prominent ethical concerns raised by clDBS is that, by inhibiting or modulating the undesirable neural states of a cognitive agent automatically, the device potentially undermines her autonomy. It has been argued that clDBS is not a threat because (...) autonomy is fundamentally relational, i.e., it essentially depends on external (e.g., social or cultural) factors. If the relational approach to autonomy includes human-computer interaction, then the mechanisms of clDBS, even if external to the brain and exerting some degree of control over the individual, may support her autonomy. However, DBS applications are substantially different from one another, each involving a specific neurological or psychiatric condition, neural target, mechanism and symptom(s), and therefore at least some of them may not fit into the relational analysis. I examine different clDBS applications for treatment resistant depression and claim that while internal capsule/ventral striatum (VC/VS) clDBS is a case of relational autonomy, subgenual cingulate gyrus (Cg25) clDBS is not. Autonomy (relational or otherwise) requires some degree of self-regulation of our motivational states, which is supported by VC/VS DBS but is absent in Cg25 DBS. In Cg25 DBS the device itself directly influences motivational states, thus substituting or overriding (instead of supporting) the auto-regulatory cognitive processes required for autonomous action. (shrink)

Schuklenk and van de Vathorst's paper is a very welcome addition to the literature on the assisted dying debate and will be of great interest to clinicians working in the field of mental health.1 Many psychiatrists will have had patients who have asked them to allow them to die, to desist in their efforts to prevent their suicide, and one of us has had personal experience, outside of professional life, of being asked to aid in someone's attempt to end their (...) life in the context of an episode of mood disorder. The person with depression asking professionals, friends and family members to aid them in ending their life is a very real phenomenon. In their discussion, Schuklenk and van de Vathorst's paper uses two principles that we endorse and add weight to their argument: namely, the reality of suffering in depression and the parity of mental and physical illness. Indeed, the case Schuklenk and van de Vathorst make is a strong one and our commentary will focus on the premise of the argument around choosing death and some empirical clarification about competence in depression and the nature of treatment-resistant depression (TRD) and its prognosis. The conceptual concern we wish to discuss in relation to assisted dying, endorsed by the state and legislature, is not linked to any moral or religious concern, or even on grounds related to ‘slippery slope’ or ‘abuse’ arguments. Rather the worry is how one could operationalise decisions around assisted dying as based on competence and capacity and view such decisions as rational. I think this concern is not limited to depressive illness, but to all decisions regarding choosing non-existence. Schuklenk and van de Vathorst offer the following useful criteria to regulate assisted suicide:1. (shrink)

Treatment-resistant symptoms complicate the clinical course of schizophrenia, and a large proportion of patients do not reach functional recovery. In consequence, polypharmacy is frequently used in treatment-refractory cases, addressing psychotic positive, negative and cognitive symptoms, treatment-emergent side effects caused by antipsychotics and comorbid depressive or obsessive-compulsive symptoms. To a large extent, such strategies are not covered by pharmacological guidelines which strongly suggest antipsychotic monotherapy. Add-on strategies comprise combinations of several antipsychotic agents and augmentations with mood stabilizers; (...) moreover, antidepressants and experimental substances are applied. Based on the accumulated evidence of clinical trials and meta-analyses, combinations of clozapine with certain second-generation antipsychotic agents and the augmentation of antipsychotics with antidepressants seem recommendable, while the augmentation with mood stabilizers cannot be considered superior to placebo. Forthcoming investigations will have to focus on innovative pharmacological agents, the clinical spectrum of cognitive deficits and the implementation of cognitive behavioral therapy. (shrink)

Obsessive–compulsive disorder is a debilitating mental health disorder that can easily become a treatment-resistant condition. Although effective therapies exist, only about half of the patients seem to benefit from them when we consider treatment refusal, dropout rates, and residual symptoms. Thus, providing effective augmentation to standard therapies could improve existing treatments. Group compassion-focused interventions have shown promise for reducing depression, anxiety, and avoidance related to various clinical problems, but this approach has never been evaluated for OCD (...) individuals. However, cultivating compassion for self and others seems crucial for OCD patients, given the accumulating research suggesting that fear of guilt, along with isolation and self-criticism, can strongly contribute to the development and maintenance of OCD. The primary aim of this pilot study was to evaluate the acceptability, tolerability, and effectiveness of an 8-week group compassion-focused intervention for reducing OCD symptoms, depression, fear of guilt and self-criticism, and increasing common humanity and compassionate self-reassuring skills in treatment-resistant OCD patients. Using a multiple baseline experimental design, the intervention was evaluated in a sample of OCD patients who had completed at least 6 months of CBT treatment for OCD, but who continued to suffer from significant symptoms. Participants were randomized to different baseline assessment lengths; they then received 8 weekly, 120-min group sessions of compassion-focused therapy for OCD, and then were tested again at post-treatment and at 1 month follow up. Despite the adverse external circumstances, by the end of treatment, all participants demonstrated reliable decreases in OCD symptoms, and these improvements were maintained at 4-week follow-up for seven of eight participants. The intervention was also associated with improvements in fear of guilt, self-criticism, and self-reassurance, but less consistent improvements in depression and common humanity. Participants reported high levels of acceptability of and satisfaction with the intervention. Results suggest that the intervention may be beneficial as either a stand-alone treatment or as an augmentation to other treatments. (shrink)

In this paper, I address the question of whether it is ever permissible to grant a request for physician-aid-in-dying (PAD) from an individual suffering from treatment-resistant depression. I assume for the sake of argument that PAD is sometimes permissible. There are three requirements for PAD: suffering, prognosis, and competence. First, an individual must be suffering from an illness or injury which is sufficient to cause serious, ongoing hardship. Second, one must have exhausted effective treatment options, and (...) one’s prospects for recovery must be poor. Third, the individual must be judged competent to request PAD. I argue that many cases of treatment-resistant depression meet the first two requirements. Thus, the key question concerns the third. I consider four features of depression that might compromise a person’s decision-making capacity. Ultimately, I conclude that PAD requests from depressed patients can be permissibly granted in some circumstances. (shrink)

Recently, several authors have argued that assisted dying may be ethically appropriate when requested by a person who suffers from serious depression unresponsive to treatment. We here present four arguments to the contrary. First, the arguments made by proponents of assisted dying rely on notions of “treatment-resistant depression” that are problematic. Second, an individual patient suffering from depression may not be justified in believing that chances of recovery are minimal. Third, the therapeutic significance of (...) hope must be acknowledged; when mental healthcare opens up the door to admitting hopelessness, there is a danger of a self-fulfilling prophecy. Finally, proponents of assisted dying in mental healthcare overlook the dangers posed to mental-health services by the institutionalization of assisted dying. (shrink)

In contrast to the fruitful relationship between psychoanalysis/psychoanalysts and the humanities, institutionalized psychoanalysis has been largely resistant to the integration of psychoanalysis with other empirical branches of knowledge, as well as clinical ones [primarily cognitive-behavioral therapy ]. Drawing from two decades of theoretical and empirical work on psychopathology, psychotherapy, and psychoanalysis, the author aims to show how a reformulation of object relations theory using psychological science may enhance a clinical-psychoanalytic understanding and treatment of suicidal depression, which constitutes (...) one of the most formidable health challenges of our time. Specifically, he rewrote the notion of Melanie Klein positions—primarily the depressive position—using extant knowledge of structure of emotions, the centrality of mental representations of the future and the toxic nature of criticism-based emotions. This reformulation enables a dialog between clinical psychoanalysis and other therapeutic schools of thought and sheds light on the understanding and treatment of suicidal depression. (shrink)

Deep brain stimulation (DBS) to different sites allows interfering with dysfunctional network function implicated in major depression. Because a prominent clinical feature of depression is anhedonia--the inability to experience pleasure from previously pleasurable activities--and because there is clear evidence of dysfunctions of the reward system in depression, DBS to the nucleus accumbens might offer a new possibility to target depressive symptomatology in otherwise treatment-resistant depression. Three patients suffering from extremely resistant forms of (...) class='Hi'>depression, who did not respond to pharmacotherapy, psychotherapy, and electroconvulsive therapy, were implanted with bilateral DBS electrodes in the nucleus accumbens. Stimulation parameters were modified in a double-blind manner, and clinical ratings were assessed at each modification. Additionally, brain metabolism was assessed 1 week before and 1 week after stimulation onset. Clinical ratings improved in all three patients when the stimulator was on, and worsened in all three patients when the stimulator was turned off. Effects were observable immediately, and no side effects occurred in any of the patients. Using FDG-PET, significant changes in brain metabolism as a function of the stimulation in fronto-striatal networks were observed. No unwanted effects of DBS other than those directly related to the surgical procedure (eg pain at sites of implantation) were observed. Dysfunctions of the reward system--in which the nucleus accumbens is a key structure--are implicated in the neurobiology of major depression and might be responsible for impaired reward processing, as evidenced by the symptom of anhedonia. These preliminary findings suggest that DBS to the nucleus accumbens might be a hypothesis-guided approach for refractory major depression. (shrink)

Abstractabstract:Recent clinical trials of psychedelic drugs aim to treat a range of psychiatric conditions in adults. MDMA and psilocybin administered with psychotherapy have received FDA designation as "breakthrough therapies" for post-traumatic stress disorder (PTSD) and treatment-resistant depression (TRD) respectively. Given the potential benefit for minors burdened with many of the same disorders, calls to expand experimentation to minors are inevitable. This essay examines psychedelic research conducted on children from 1959 to 1974, highlighting methodological and ethical flaws. It (...) provides ethics and policy recommendations for psychedelics research involving children and adolescents, including recognizing that the psychedelic experience is an ineffable one that makes informed proxy consent for parents, guardians, and others especially challenging. Psychedelic experiences are associated with novel benefits and risks, such as significant personality changes, shifts in fundamental values, and possible re-exposure to traumatic memories. These effects may alter the process of personality development in minors. Recommendations for ethically sound psychedelics research in minors include strict adherence to eligibility criteria, including a comprehensive family and individual psychiatric, substance use, and trauma history. An age-appropriate assent process that includes considerations related to the use of therapeutic touch should be developed. In addition, oversight by data safety monitoring boards and patient and family advocates, coupled with the adoption of pharmacoequity best practices, will help to ensure safety and fairness of psychedelics research in children. (shrink)

Introduction: Electroconvulsive therapy is a commonly used brain stimulation treatment for treatment-resistant or severe depression. This study was planned to find the effects of ECT on brain connectivity by conducting a systematic review and coordinate-based meta-analysis of the studies performing resting state fMRI in patients with depression receiving ECT.Methods: We systematically searched the databases published up to July 31, 2020, for studies in patients having depression that compared resting-state functional connectivity before and after a (...) course of pulse wave ECT. Meta-analysis was performed using the activation likelihood estimation method after extracting details about coordinates, voxel size, and method for correction of multiple comparisons corresponding to the significant clusters and the respective rsFC analysis measure with its method of extraction.Results: Among 41 articles selected for full-text review, 31 articles were included in the systematic review. Among them, 13 articles were included in the meta-analysis, and a total of 73 foci of 21 experiments were examined using activation likelihood estimation in 10 sets. Using the cluster-level interference method, one voxel-wise analysis with the measure of amplitude of low frequency fluctuations and one seed-voxel analysis with the right hippocampus showed a significant reduction in the left cingulate gyrus and a significant increase in the right hippocampus with the right parahippocampal gyrus, respectively. Another analysis with the studies implementing network-wise resting state functional connectivity showed a significant increase in bilateral posterior cingulate cortex. There was considerable variability as well as a few key deficits in the preprocessing and analysis of the neuroimages and the reporting of results in the included studies. Due to lesser studies, we could not do further analysis to address the neuroimaging variability and subject-related differences.Conclusion: The brain regions noted in this meta-analysis are reasonably specific and distinguished, and they had significant changes in resting state functional connectivity after a course of ECT for depression. More studies with better neuroimaging standards should be conducted in the future to confirm these results in different subgroups of depression and with varied aspects of ECT. (shrink)

Aim: Understanding the effects of psychotherapy is a crucial concern for both research and clinical practice, especially when outcome tends to be negative. Yet, while outcome is predominantly evaluated by means of quantitative pre-post outcome questionnaires, it remains unclear what this actually means for patients in their daily lives. To explore this meaning, it is imperative to combine treatment evaluation with quantitative and qualitative outcome measures. This study investigates the phenomenon of non-improvement in psychotherapy, by complementing quantitative pre-post outcome (...) scores that indicate no reliable change in depression symptoms with a qualitative inquiry of patients’ perspectives. Methods: The study took place in the context of a Randomized Controlled Trial evaluating time-limited psychodynamic and cognitive behavioural therapy for major depression. A mixed methods study was conducted including patients’ pre-post outcome scores on the BDI-II-NL and post treatment Client Change Interviews. Nineteen patients whose data showed no reliable change in depression symptoms were selected. A grounded theory analysis was conducted on the transcripts of patients’ interviews. Findings: From the patients’ perspective, non-improvement can be understood as being stuck between knowing versus doing, resulting in a stalemate. Positive changes (mental stability, personal strength and insight) were stimulated by therapy offering moments of self-reflection and guidance, the benevolent therapist approach and the context as important motivations. Remaining issues (ambition to change but inability to do so) were attributed to the therapy hitting its limits, patients’ resistance and impossibility and the context as a source of distress. “No change” in outcome scores therefore seems to involve a “partial change” when considering the patients’ perspectives. Conclusion: The study shows the value of integrating qualitative first-person analyses into standard quantitative outcome evaluation and particularly for understanding the phenomenon of non-improvement. It argues for more multi-method and multi-perspective research to gain a better understanding of (negative) outcome and treatment effects. Implications for both research and practice are discussed. (shrink)

IntroductionTranscranial magnetic stimulation is a consolidated procedure for the treatment of depression, with several meta-analyses demonstrating its efficacy. Theta-burst stimulation is a modification of TMS with similar efficacy and shorter session duration. The geriatric population has many comorbidities and a high prevalence of depression, but few clinical trials are conducted specifically for this age group. TBS could be an option in this population, offering the advantages of few side effects and no pharmacological interactions. Therefore, our aim is (...) to investigate the efficacy of TBS in geriatric depression.Clinical trial registration[https://clinicaltrials.gov/ct2/], identifier [NCT04842929]. (shrink)

Antidepressant medication and evidence-based psychotherapy have largely equivalent efficacy in the management of the common, less severe grades of depression. As a result, several national guidelines recommend that either can be used in the treatment of this disorder. Psychotherapy, however, differs in that it assists insight into how the depressed person appraises and manages the stressors that frequently trigger depressive episodes. I argue that the self-knowledge achieved through psychotherapy has moral value in that it promotes the autonomy of (...) stressor-related decisions. I further argue that such an effect comprises a compelling moral reason for doctors to see evidence-based psychotherapy not as merely optional, but as a necessary treatment for their patients with depression. (shrink)

Background Psychiatric electroceutical interventions (PEIs) use electrical or magnetic stimulation to treat mental disorders and may raise different ethical concerns than other therapies such as medications or talk therapy. Yet little is known about stakeholders’ perceptions of, and ethical concerns related to, these interventions. We aimed to better understand the ethical concerns of a variety of stakeholder groups (patients with depression, caregivers of patients, members of the public, and psychiatrists) regarding four PEIs: electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (...) (rTMS), deep brain stimulation (DBS), and adaptive brain implants (ABI).Methods We conducted a national survey of these four stakeholder groups, using an embedded video vignette experiment depicting a patient with treatment-resistant depression and her psychiatrist discussing the possibility of treatment with one of the four PEIs.Results Participants’ ethical concerns varied by stakeholder group, by PEI, and by the interaction of the two. The three non-clinician groups tended to have similar ethical concerns, but to differ from psychiatrists. Similar concerns were raised with regard to the two implantable technologies, DBS and ABI. Overall, there was relatively little concern about the involuntary use of PEIs, though some expressed concern about the adequacy of information provided during the consent process. There was also significant concern that patients may not receive helpful therapies.Conclusions To our knowledge, this is the first national survey that includes multiple stakeholder groups and multiple PEI modalities. A better understanding of the ethical concerns of stakeholders can help to shape clinical practice and health care policy regarding PEIs. (shrink)

BackgroundOther Specified Feeding and Eating Disorders are characterized by less frequent symptoms or symptoms that do not meet full criteria for another eating disorder. Despite its high prevalence, limited research has examined differences in severity and treatment outcome among patients with OSFED compared to threshold EDs [Anorexia Nervosa, Bulimia Nervosa, and Binge Eating Disorder ]. The purpose of the current study was to examine differences in clinical presentation and treatment outcome between a heterogenous group of patients with OSFED (...) or threshold EDs.MethodPatients with threshold EDs or OSFED presenting for eating disorder treatment completed self-report questionnaires at intake and discharge to assess eating disorder symptoms, depression symptoms, impairment, and self-esteem.ResultsAt intake, OSFED patients showed lower eating concerns compared to patients with BN, but similar levels compared to AN and BED. The OSFED group showed higher restraint symptoms compared to BED, and similar restraint to AN and BN. Global symptoms as well as shape and weight concerns were similar between OSFED and threshold ED groups. There were no differences between diagnostic groups in self-esteem, depression scores, or symptom change from intake to discharge.DiscussionOur findings suggest that individuals with OSFED showed largely similar ED psychopathology and similar decreases in symptoms across treatment as individuals diagnosed with threshold EDs. Taken together, findings challenge the idea that OSFED is less severe and more resistant to treatment than threshold EDs. (shrink)

Volunteering, or taking part in unpaid work for the benefit of others, can be a powerful positive experience with returns to both individual well-being and community projects. Volunteering is positively associated with mental health in observational studies with community samples but has not been systematically examined as a potential part of treatment interventions with clinical adolescent samples. In this manuscript, we review the empirical evidence base connecting volunteerism to mental health and well-being, outline potential mechanisms based in the theoretical (...) literature from developmental science, and discuss the existing clinical approaches that support community volunteering as a part of treatment. Drawing on this review, we propose that including volunteering as a component of clinical treatment approaches for adolescent depression can be a powerful intervention for adolescents. (shrink)

The recent push to extend physician-aid-in-dying (PAD) to psychiatric conditions has significantly altered the ethical landscape surrounding psychiatric judgments concerning treatment-refractory il...

Although being generally safe, the use of Deep Brain Stimulation has been associated with a significant number of patients experiencing postoperative psychological and neurological harm within experimental trials. A proportion of these postoperative severe adverse effects have lead to the decision to medically prescribe device deactivation or removal. However, there is little debate in the literature as to what is in the patient’s best interest when device removal has been prescribed; in particular, what should be the conceptual approach to ethically (...) guide the decision to remove or maintain implants. The purpose of this article is to examine the ethical issues raised when patients refuse brain device explantation despite medical prescription. In order to illustrate these issues, we report and discuss a clinical case involving a patient suffering from treatment resistant depression who experienced forms of postoperative self-estrangement, as well as suicidal attempts, but who resists giving consent to device explantation. (shrink)

Case reports about patients undergoing Deep Brain Stimulation (DBS) for various motor and psychiatric disorders - including Parkinson’s Disease, Obsessive Compulsive Disorder, and Treatment Resistant Depression - have sparked a vast literature in neuroethics. Questions about whether and how DBS changes the self have been at the fore. The present chapter brings these neuroethical debates into conversation with recent research in moral psychology. We begin in Section 1 by reviewing the recent clinical literature on DBS. In Section (...) 2, we consider whether DBS poses a threat to personal identity. In Section 3 we argue for engagement with recent empirical work examining judgements of when identity changes. We conclude in Section 4 by highlighting a range of ethical issues raised by DBS, including various cross-cultural considerations. (shrink)

This study examined Flow with Nature treatment, which is an integrative intervention based on eco and environmental psychology, psychotherapeutic theories and professional psychological practice. FWN is intended for depression rehabilitation with the help of social support, nature environments and FWN exercises. Exercises encourage sensing the environment, mindful awareness, psychological processing and focusing on the future. The FWN treatment proceeds in separate stages, which emphasise nature, group and FWN exercises differently. This study focused on the experiences of the (...) participants in the FWN treatment. Finnish adults who had been diagnosed with clinical depression took part in the FWN treatment and answered feedback questions. Answers were analysed using theory-based content analysis. Data were collected between spring 2019 and spring 2020. The majority of the participants were women and on average 44 years old. Content analysis revealed that the participant feedback answers were in agreement with the central theoretical themes of FWN. The participants emphasised the significance of nature, social support and exercises differently. Moreover, the significance of these ingredients differed according to the stages of treatment: in the horizon stage restorative and comprehensive nature experiences, in the growth stage social support and in the path stage environmental self-regulation were emphasised. These results are in accordance with the objectives of the stages and seem to support the phase-based rationale. The participants’ experiences of the key elements of the intervention, social support and nature environment were experienced mainly positively, which supports their inclusion in future intervention versions. In the future, FWN exercises should be developed to better enable participants’ possibilities for concentration and being present in the moment. Exercises should also be simplified to match the target group’s cognitive abilities. (shrink)

The concept of vulnerability is widely used in research ethics to signal attention to participants who require special protections in research. However, this concept is vague and under‐theorized. There is also growing concern that the dominant categorical approach to vulnerability (as exemplified by research ethics regulations and guidelines delineating vulnerable groups) is ethically problematic because of its assumptions about groups of people and is, in fact, not very guiding. An agreed‐upon strategy is to move from categorical towards analytical approaches (focused (...) on analyzing types and sources of vulnerability) to vulnerability. Beyond this agreement, however, scholars have been advancing competing accounts of vulnerability without consensus about its appropriate operationalization in research ethics. Based on previous debates, we propose that a comprehensive account of vulnerability for research ethics must include four components: definition, normative justifications, application, and implications. Concluding that no existing accounts integrate these components in a functional (i.e., practically applicable) manner, we propose an integrative and functional account of vulnerability inspired by pragmatist theory and enriched by bioethics literature. Using an example of research on deep brain stimulation for treatment‐resistant depression, we illustrate how the integrative‐functional account can guide the analysis of vulnerability in research within a pragmatist, evidence‐based approach to research ethics. While ultimately there are concerns to be addressed in existing research ethics guidelines on vulnerability, the integrative‐functional account can serve as an analytic tool to help researchers, research ethics boards, and other relevant actors fill in the gaps in the current landscape of research ethics governance. (shrink)

The Western world is experiencing a resurgence of interest in the therapeutic potential of psychedelics, most of which are derived from plants or fungi with a history of Indigenous ceremonial use. Recent research has revealed that psychedelic compounds have the potential to address treatment‐resistant depression and anxiety, as well as post‐traumatic stress disorder and addictions. These findings have contributed to the decriminalization of psychedelics in some jurisdictions and their legalization in others. Despite psychedelics’ opaque legal status, numerous (...) companies and individuals are profiting from speculative investments with few, if any, benefits accruing to Indigenous Peoples. In this paper, we suggest that the aptly named “psychedelic renaissance,” like the European Renaissance, is made possible by colonial extractivism. We further suggest that Indigenous philosophical traditions offer alternative approaches to reorient the “psychedelic renaissance” towards a more equitable future for Indigenous Peoples, psychedelic medicines, and all our relations. (shrink)

Drawing the line on physician assistance in physician-assisted death continues to be a contentious issue in many legal jurisdictions across the USA, Canada and Europe. PAD is a medical practice that occurs when physicians either prescribe or administer lethal medication to their patients. As more legal jurisdictions establish PAD for at least some class of patients, the question of the proper scope of this practice has become pressing. This paper presents an argument for restricting PAD to the terminally ill that (...) can be accepted by defenders as well as critics of PAD for the terminally ill. The argument appeals to fairness-based paternalism and the social meaning of medical practice. These two considerations interact in various ways, as the paper explains. The right way to think about the social meaning of medical practice bears on fair paternalism as it relates to PAD and vice versa. The paper contends that these considerations have substantial force when directed against proposals to extend PAD to non-terminally ill patients, but considerably less force when directed against PAD for the terminally ill. The paper pays special attention to the case of non-terminally ill patients who suffer from treatment-resistant depression, as these patients present a potentially strong case for extending PAD beyond the terminally ill. (shrink)

This multi-centre research investigates the effects of dance movement therapy (DMT) on participants diagnosed with depression. In total, 109 persons participated in the study in various locations in Finland. The participants were 39 years old, on average (range = 18–64 years), and most were female (96%). All participants received treatment as usual (TAU). They were randomised into DMT+TAU (n = 52) or TAU-only (n = 57). The participants in the DMT + TAU group were offered 20 DMT sessions (...) twice a week for 10 weeks in addition to standard care. The measurement points included pre-treatment measurement at the baseline, post-treatment measurement at the end of the intervention, and a follow-up measurement 3 months afterward. The observed effects of the intervention among participants in the DMT+TAU group were a greater reduction in depression (BDI-I) and in indicators of physical and psychological distress (CORE-OM and SCL-90) in comparison to the participants who received TAU-only. At the 3-month follow-up, the corrected between-group effect sizes (ES) were medium and in favour of the DMT+TAU group (d = 0.60–0.72). These results are in line with the increasing number of research studies showing the benefits of DMT intervention among participants with depression, and these results indicate that DMT may improve the effectiveness of standard care. (shrink)

In their article, “Patients’ beliefs about deep brain stimulation (DBS) for treatment resistant depression,” Lawrence, Kaufmann, DeSilva, and Appelbaum analyze the responses of 24 psychiatric inpat...

BackgroundDepressive disorders are a common form of psychiatric illness and cause significant disability. Regulation authorities, the medical profession and the public require high safety standards for antidepressants to protect vulnerable psychiatric patients. Ketamine is a dissociative anaesthetic and a derivative of a hallucinogen. Its abuse is a major worldwide public health problem. Ketamine is a scheduled drug and its usage is restricted due to its abuse liability. Recent clinical trials have reported that ketamine use led to rapid antidepressant effects in (...) patients suffering from treatment-resistant depression. However, various flaws in study designs, and possible biased reporting of results, may have influenced those findings. Further analyses of ketamine use are needed to ensure patient safety.DiscussionThe use of ketamine in research and treatment of depressive disorders is controversial. Recently, mental health professionals raised ethical concerns about an ongoing ketamine trial in the UK. Also, a Canadian agency reviewed the existing evidence and did not recommend prescribing ketamine to treat depressive disorders. Findings obtained from tightly controlled research settings cannot be easily translated to clinical practice as substance abuse is commonly comorbid with depressive disorders. An effective antidepressant should reduce severity of depressive symptoms without liability problems. Although the US FDA has not approved the use of ketamine to treat depressive disorders, some psychiatrists offer off-label repeat prescription of ketamine. Prescribing ketamine for treating depressive disorders requires substantial empirical evidence. Clinicians should also consider research findings on ketamine abuse. Depressive disorders can be chronic conditions and the current evidence does not rule out the risk of substance abuse after repeat prescription of ketamine. Off-label ketamine use in treating depressive disorders may breach ethical and moral standards, especially in countries seriously affected by ketamine abuse. This article presents two real-world clinical vignettes which highlight ethical principles and theories, including autonomy, nonmaleficience, fidelity and consequentialism, as related to off-label ketamine use.ConclusionWe urge clinicians to minimise the risk of harming patients by considering the empirical evidence on ketamine properties and attempting all standard antidepressant therapies before considering the off-label use of ketamine. (shrink)

Precision targeting of specific white matter bundles that traverse the subcallosal cingulate has been linked to efficacy of deep brain stimulation for treatment resistant depression. Methods to confirm optimal target engagement in this heterogenous region are now critical to establish an objective treatment protocol. As yet unexamined are the time-frequency features of the SCC evoked potential, including spectral power and phase-clustering. We examined these spectral features—evoked power and phase clustering—in a sample of TRD patients with implanted (...) SCC stimulators. Electroencephalogram was recorded during wakeful rest. Location of electrical stimulation in the SCC target region was the experimental manipulation. EEG was analyzed at the surface level with an average reference for a cluster of frontal sensors and at a time window identified by prior study. Morlet wavelets generated indices of evoked power and inter-trial phase clustering. Enhanced phase clustering at theta frequency was observed in every subject and was significantly correlated with SCC-EP magnitude, but only during left SCC stimulation. Stimulation to dorsal SCC evinced stronger phase clustering than ventral SCC. There was a weak correlation between phase clustering and white matter density. An increase in evoked delta power was also coincident with SCC-EP, but was less consistent across participants. DBS evoked time-frequency features index mm-scale changes to the location of stimulation in the SCC target region and correlate with structural characteristics implicated in treatment optimization. Results also imply a shared generative mechanism between evoked potentials evinced by electrical stimulation and evoked potentials evinced by auditory/visual stimuli and behavioral tasks. Understanding how current injection impacts downstream cortical activity is essential to building new technologies that adapt treatment parameters to individual differences in neurophysiology. (shrink)

Both ethicists and lawyers accept that a provider – be it a researcher or a clinician – should provide sufficient information for a reasonable person to make an informed decision about whether they wish to go ahead with the proposed intervention or treatment.1 They are bound to do so both because they have an ethical responsibility to preserve the individual’s autonomous decision making, and, in many countries, because the law obliges them to. In this month’s issue of the JME, (...) three articles tackle ethical issues relating to consent in different contexts. Overarching these analyses is the pragmatic question of whether the process of taking consent in itself might alter the outcomes, and whether, in doing so, it can undermine the initial therapeutic or research goal – so creating another ethical question of what to prioritise. Psilocybin is entering Phase III trials to evaluate its effect on treatment resistant depression and cancer related depression and anxiety; earlier trials have shown sustained symptom reduction in these populations. Smith and Sisti examine whether a form of enhanced consent is ethically required for these drugs.2 They explore how to adequately consent for ‘therapeutic touch’ in a future altered state; the rare but significant mental health risks including trauma re-exposure; and the potential for a personality change given the intense experiences which many subjects have reported. They illustrate the potential for personality change with an example regarding the spiritual experiences which can occur with serotonergic psychedelics, and suggest that ‘agnostic or atheist patients may take the development of a newfound sense of spirituality or belief in God to …. (shrink)