Efficacy of new-generation antidepressants assessed with the Montgomery-Asberg depression rating scale, the gold standard clinician rating scale : a meta-analysis of randomised placebo-controlled trials

It has been claimed that efficacy estimates based on the Hamilton Depression Rating-Scale (HDRS) underestimate antidepressants true treatment effects due to the instrument's poor psychometric properties. The aim of this study is to compare efficacy estimates based on the HDRS with the gold standard procedure, the Montgomery-Asberg Depression Rating-Scale (MADRS)

Statistically significant antidepressant-placebo differences on subjective symptom-rating scales do not prove that the drugs work : effect Size and method bias matter!

Following the publication of a recent meta-analysis by Cipriani et al., various opinion leaders and news reports claimed that the effectiveness of antidepressants has been definitely proven. E.g., Dr. Pariante, spokesperson for the Royal College of Psychiatrists, stated that this study “finally puts to bed the controversy on antidepressants, clearly showing that these drugs do work in lifting mood and helping most people with depression” (https://www.theguardian.com/science/2018/feb/21/the-drugs-do-work-antidepressants-are-effective-study-shows). We surely would embrace drug treatments that effectively help most people with depression, but based on work that has contested the validity of mostly industry-sponsored antidepressant trials we remain skeptical about antidepressants' clinical benefits. The most recent meta-analysis indeed concludes that antidepressants are more effective than placebo but also acknowledges that risk of bias was substantial and that the mean effect size of d = 0.3 was modest. Unfortunately, no clarification is given what this effect size means and whether it can be expected to be clinically significant in real-world routine practice. In this opinion paper we therefore ponder over how the reported effect size of d = 0.3 relates to clinical significance and how method bias undermines its validity, in order that the public, clinicians, and patients can judge for themselves whether antidepressants clearly work in most people with depression

Guidelines for the pharmacological acute treatment of major depression : conflicts with current evidence as demonstrated with the German S3-guidelines

Several international guidelines for the acute treatment of moderate to severe unipolar depression recommend a first-line treatment with antidepressants (AD). This is based on the assumption that AD obviously outperform placebo, at least in the case of severe depression. The efficacy of AD for severe depression can only be definitely clarified with individual patient data, but corresponding studies have only been available recently. In this paper, we point out discrepancies between the content of guidelines and the scientific evidence by taking a closer look at the German S3-guidelines for the treatment of depression. Based on recent studies and a systematic review of studies using individual patient data, it turns out that AD are marginally superior to placebo in both moderate and severe depression. The clinical significance of this small drug-placebo-difference is questionable, even in the most severe forms of depression. In addition, the modest efficacy is likely an overestimation of the true efficacy due to systematic method biases. There is no related discussion in the S3-guidelines, despite substantial empirical evidence confirming these biases. In light of recent data and with their underlying biases, the recommendations in the S3-guidelines are in contradiction with the current evidence. The risk-benefit ratio of AD for severe depression may be similar to the one estimated for mild depression and thus could be unfavorable. Downgrading of the related grade of recommendation would be a logical consequence

"Es geht mir gut, wenn es ihm gut geht"

Menschen im Wachkoma, oder in einem Folgezustand nach einem schweren Schädel-Hirn-Trauma, stellen für Pflegende und Betreuende, eine besondere Herausforderung dar. Eine Herausforderung auch für die Gesellschaft, da diese Menschen für lange Zeit versorgt und betreut werden müssen und diese Betreuung sehr kosten- und personalintensiv ist. Mehr als die Hälfte der Betroffenen werden in häuslicher Umgebung versorgt und gepflegt. In qualitativen Interviews wurden für diese Diplomarbeit das Erleben der Pflegesituation und die Motive der Angehörigen für die Übernahme der Pflege erhoben, sowie die Änderungen die sich im Leben der pflegenden Angehörigen dadurch ergeben haben. Die Betroffenen eines Schädel-Hirn-Traumas sind häufig sehr jung. Daher ist die Dauer der Pflegetätigkeit schwer einschätzbar und kann über viele Jahre und Jahrzehnte andauern. Eine Besonderheit stellt der Umstand dar, dass es auch viele Jahre nach der Verletzung noch zu Verbesserungen des Zustandes kommen kann. Die ersten zwei Jahre nach Übernahme der Pflegetätigkeit erwiesen sich für die Angehörigen als die schwierigste Zeit. Sie mussten lernen mit dem Verlust der Gesundheit des Betroffenen zu leben, Einschränkungen finanzieller und sozialer Art verkraften und mit verschiedenen schwierigen Situationen im Alltag der Pflege fertig zu werden. Als Ergebnis kann gesagt werden, dass die pflegenden Angehörigen alle eine dauerhafte Veränderung ihrer Lebenssituation erfuhren. Die Verletzungen und die daraus resultierenden Beeinträchtigungen eines nahen Angehörigen und die Übernahme der Pflege bewirkten eine völlig neue Lebenssituation für die Pflegenden. Sie gaben zum Teil den Beruf auf, es veränderte ihre soziale Situation, den Freundeskreis, die finanzielle Lebensplanung und die Zukunft. Angehörige die es schafften mit diesen schwierigen Situationen umzugehen, sich Entlastungen zu organisieren und soziale Kontakte aufrecht erhielten, kamen mit den Belastungen am Besten zurecht. Die pflegenden Angehörigen schafften es für sich und die Betroffenen eine gute Lebensqualität zu erreichen. Unterstützung bekommen die pflegenden Angehörigen vor allem von weiteren Familienmitgliedern, aber auch durch Mobile Dienste und Therapeuten. Verbesserungen würden sich die pflegenden Angehörigen vor allem in finanzieller Hinsicht wünschen, sowie Erleichterungen bei bürokratischen Abläufen.People in a persistent vegetative state or in a state following severe traumatic brain injury are a particular challenge for nurses and caregivers, and a challenge for society, too, as these patients have to be cared for and supported for a long time and this care is also costly and staff-intensive. More than half of the patients affected are supported and cared for at home. Qualitative interviews carried out for this diploma thesis show the reasons why relatives take over care as well as the changes that this has brought about in the lives of caregiving relatives and what the experience of caregiving means for them. People affected by traumatic brain injury are often very young. Therefore the duration of care is difficult to estimate and may take many years or decades. A special aspect of this situation is that even years after the injury the patients’ state may improve. The first two years after taking over care have proved to be the most difficult for relatives. They have to learn to come to terms with the patients’ loss of health, to put up with financial and social restrictions and with various difficult situations in everyday care. The results show that all caregiving relatives have experienced a lasting change in their life situations. Injuries and sustainable impairment of a close relative resulting from this cause a completely new life situation for the caregivers. Part of them have given up their jobs, their social situation has changed, as have friends, financial career planning, and their future. Relatives who have managed to deal with these difficult situations , to organise help and to keep up social contacts have been able to cope with the stress they are experiencing. These caregivers have succeeded in gaining good life quality for themselves and the patients. Support for caregiving relatives above all comes from other family members as well as mobile services and therapists. Caregiving relatives would like to see improvement in particular with regard to financial aspects as well as bureaucratic procedures

LGBTI e salute psichica - Fatti e modelli esplicativi

Zusammenfassung: Lesbische, schwule, bisexuelle, transgender und intersexuelle (LSBTI) Menschen scheinen ein erhöhtes Risiko für psychische Erkrankungen und Suizidalität zu haben, wie aus vielen internationalen Studien hervorgeht. In diesem Beitrag wird die aktuelle Studienlage dargestellt und auf methodologische Herausforderungen eingegangen. Während für lesbische, schwule und bisexuelle Menschen die Evidenz für das höhere Erkrankungsrisiko robust erscheint, ist die Datenlage zu Transgender und Intersexualität noch eher dürftig, die Ergebnisse sprechen aber auch hier für ein erhöhtes Risiko. Weiters werden in diesem Beitrag neuere wissenschaftlich fundierte Erklärungsmodelle zur psychischen Gesundheit von LSBTI Menschen vorgestellt. Diese haben pathologisierende Ansichten über LSBTI abgelöst und fokussieren auf die Folgen gesellschaftlicher Homo-, Bi-, Trans- und Interphobie. Daraus resultierende verschiedene Formen von Minoritätenstress, welchen LSBTI Menschen oder jene, die als LSBTI wahrgenommen werden, ausgesetzt sind, können das erhöhte Krankheitsrisiko gut erklären. Die Kenntnis des Erkrankungsrisikos von LSBTI Patient*innen und der zugrundeliegenden pathogenetischen Prozesse ist für die psychotherapeutische Praxis relevant.Schlüsselwörter: psychische Krankheit, Gesundheit, Suizid, Lesben, Schwule, Bisexuelle, Homosexualität, Transgender, IntersexualitätSummary: Lesbian, gay, bisexual, transgender, and intersex (LGBTI) individuals seem to be at increased risk for mental disorders and suicidality, as reported in numerous international studies. This paper gives an overview of the current empirical literature and discusses methodological challenges. The evidence for an increase of risk seems to be robust for lesbian, gay, and bisexual individuals; data about transgender and intersex individuals are still rather sparse but hint at an increase of risk, too. Furthermore, this paper discusses current scientific explanatory models about the mental health of LGBTI individuals. These current models overcame old pathologizing views of LGBTI and focus on the impact of society’s homo-, bi-, trans-, and interphobia. The resulting different forms of minority stress that LGBTI individuals or those who are perceived as LGBTI are faced with can well explain the increased risk for mental disorders. Being aware of the mental health risk of LGBTI patients and underlying pathogenetic processes is important for psychotherapeutic practice.Key words: mental disorder, health, suicide, lesbians, gays, bisexuals, homosexuality, transgender, intersexLes personnes lesbiennes, gay, bisexuelles, transgenres et intersexuées (LGBTI) présentent un risque de maladies psychologiques et une tendance suicidaire accrus, comme le montrent de nombreuses études internationales. Cet article présente la situation actuelle et aborde les défis méthodologiques. Alors que les données sur le risque pathologique accru semblent fiables pour les personnes lesbiennes, gay et bisexuelles, le volume de données pour les personnes transgenres et intersexuées est encore limité, même si les résultats indiquent également un risque accru. Cet article présente également des nouveaux modèles d’explications scientifiques de la santé psychologique des membres de la communauté LGBTI, qui ont remplacé les approches pathologisantes des LGBTI et se concentrent sur les conséquences de l’homo-, bi-, trans- et interphobie dans la société. Les différentes formes de pressions sur les minorités qui en résultent, auxquelles sont exposés les membres de la communauté LGBTI ou les personnes perçues comme appartenant à la communauté LGBTI, expliquent bien le risque pathologique accru. Connaître le risque pathologique des patientes et des patients LGBTI ainsi que les processus pathogénétiques sous-jacents est pertinent pour la pratique de la psychothérapie.Mots-clés: psychologique, maladie, santé, suicide, lesbienne, gay, bisexuel, homosexualité, transgenre, intersexuationRiassunto: Le persone lesbiche, gay, bisessuali, transgender e intersessuali (LGBTI) sembrano avere una predisposizione elevata alle malattie psichiche e al suicidio, come emerge da numerosi studi internazionali. Questo contributo presenta la situazione attuale degli studi e approfondisce le relative sfide metodologiche. Mentre per le persone lesbiche, gay e bisessuali, l'evidenza per un rischio accresciuto di malattia pare solida, i dati relativi al transgenderismo e all'intersessualità sono ancora insufficienti, i risultati anche in questo caso indicano però un rischio elevato. In questo contributo vengono inoltre presentati i più recenti modelli esplicativi scientificamente fondati relativi alla salute psichica di persone LGBTI. Questi hanno sostituito le visioni patologizzanti di LGBTI e si concentrano sulle conseguenze dell'omofobia, bifobia, transfobia e interfobia insite nella società. Le diverse forme di stress da minoranza che ne risultano, alle quali le persone LGBTI, o quelle percepite come tali, sono esposte, rappresentano una buona spiegazione della predisposizione elevata alle malattie. La conoscenza del rischio di malattia delle/dei pazienti LGBTI e dei processi patogenetici che ne sono all'origine, sono rilevanti per la prassi psicoterapeutica.Parole chiave: malattia, salute, psichica, suicidio, lesbica, gay, bisessuale, omosessualità, transgenderismo, intersessualit

Effects of gatekeeper trainings from the Austrian national suicide prevention program

BackgroundThe development and implementation of gatekeeper trainings were first goals in the national suicide prevention strategy “Suicide Prevention Austria” (SUPRA). The current study aims to assess the short- and longer-term effects of the SUPRA gatekeeper trainings in comparison with established gatekeeper trainings.MethodsWe evaluated 28 gatekeeper trainings including 427 participants by assessing improvement of knowledge (facts about suicide and suicide prevention), gatekeeper self-efficacy and attitudes, and gatekeeper behavior (e.g., asking depressed people about suicide). Assessments were immediately before and after the gatekeeper trainings, with an additional follow-up 6 months later. Effects were compared with benchmark effects of established gatekeeper trainings.ResultsThere were substantial improvements in knowledge, self-efficacy and attitudes immediately after the training, comparable or larger than known from evaluations of established gatekeeper trainings. Most of these changes were upheld in the follow-up assessment, with effects comparable to other gatekeeper trainings. There was only a small increase of self-reported gatekeeper behavior, in line with results from other gatekeeper trainings.ConclusionThe SUPRA gatekeeper training had some beneficial effects in the short- and longterm, with effect sizes comparable to established gatekeeper trainings

Suicidality and other severe psychiatric events with duloxetine : re-analysis of safety data from a placebo-controlled trial for juvenile fibromyalgia

The final publication is available at IOS Press through http://dx.doi.org/10.3233/JRS-200033BACKGROUND: In antidepressant trials for pediatric patients with depression or anxiety disorders, the risk of suicidal events and other severe psychiatric adverse events such as aggression and agitation is increased with antidepressants relative to placebo. OBJECTIVE: To examine whether largely mentally healthy adolescents treated for a non-psychiatric condition are also at increased risk of suicidality and other severe psychiatric disorders. METHODS: This is a re-analysis of a placebo-controlled duloxetine trial for juvenile fibromyalgia based on the main journal article and additional data published in the online supplementary material and on ClinicalTrials.gov. Both serious adverse events related to psychiatric disorders and adverse events leading to treatment discontinuation were defined as severe treatment-emergent psychiatric adverse events. RESULTS: We found that a significant portion of adolescents had treatment-emergent suicidal ideation and behaviour as well as other severe psychiatric adverse events with duloxetine, but no such events were recorded on placebo. The incidence of severe treatment emergent psychiatric adverse events was statistically significantly higher with duloxetine as compared to placebo. CONCLUSIONS: Antidepressants may put adolescents at risk of suicidality and other severe psychiatric disorders even when the treatment indication is not depression or anxiety

Effect of the FDA black box suicidality warnings for antidepressants on suicide rates in the USA : signal or noise?

Background: Some authors claimed that the US Food and Drug Administration (FDA) black box warning on treatment-emergent suicidality with antidepressants in adolescents (issued 2004) and young adults (issued 2006) led to an increase of suicides, based on the analyses of ecological data with debatable assumptions about putative changes in suicide rates. Aims: To explore if putative changes in suicide rates in adolescents and young adults at the time of the FDA warnings is a detectable signal in the data or compatible with random fluctuations. Method: We applied different changepoint analyses for adolescent and young adult suicide rates from 1981 to 2019 in the USA. Results: Changepoint analysis did not support a detrimental effect of the FDA black box warnings. The downward trend of suicides reversed several years after the warning in adolescents (2007–2009) and many years before in young adults (1999–2001). Limitations: Our analyses cannot rule out detrimental effects of the FDA warnings. However, even if there was such an effect, it was likely small and indistinguishable from random fluctuations in the available suicide data. Conclusion: There is no detectable change of trend in adolescent or young adult suicide rates in line with a detrimental effect of the FDA black box warnings on treatment-emergent suicidality