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Background: Patients with cancer are particularly vulnerable to depressive experiences, ranging from severe emotional reactions to proper depressive syndromes, including major depression. These experiences may deeply affect the course and outcome of the disease. The aim of this study was to assess the efficacy acceptability of antidepressants on the continuum of depressive experiences in patients suffering from cancer., Methods: MEDLINE, EMBASE, PsycINFO, CENTRAL, as well as websites of regulatory agencies, clinical trial repositories and pharmaceutical companies, were systematically searched for published and unpublished randomised trials assessing the efficacy of antidepressants versus placebo in patients with cancer. Efficacy of antidepressants at the end of the study was the primary outcome. The review protocol was registered with PROSPERO (CRD42014013440)., Results: A total of 19 studies contributed to the analysis. Antidepressants (particularly the selective serotonin-reuptake inhibitors and mianserin) were more effective than placebo in relieving depressive experiences in both patients with major depression or depressive symptoms (standardised mean difference -0.596, 95% confidence interval -1.041 to -0.150), as well as in patients with other cancer-related distressing symptoms (standardised mean difference -0.229, 95% confidence interval -0.419 to -0.039). We found evidence that efficacy was positively associated with length of treatment. No differences between antidepressants and placebo were found in terms of overall acceptability., Conclusions: Antidepressants should be considered as one treatment option for relieving the burden of depressive experiences in patients with cancer., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Background: Major depression and other depressive conditions are common in people with cancer. These conditions are not easily detectable in clinical practice, due to the overlap between medical and psychiatric symptoms, as described by diagnostic manuals such as the Diagnostic and Statistical Manual of Mental Disorders (DSM) and International Classification of Diseases (ICD). Moreover, it is particularly challenging to distinguish between pathological and normal reactions to such a severe illness. Depressive symptoms, even in subthreshold manifestations, have been shown to have a negative impact in terms of quality of life, compliance with anti-cancer treatment, suicide risk and likely even the mortality rate for the cancer itself. Randomised controlled trials (RCTs) on the efficacy and tolerability of antidepressants in this population group are few and often report conflicting results., Objectives: To assess the effects and acceptability of antidepressants for treating depressive symptoms in adults (18 years or older) with cancer (any site and stage)., Search Methods: We searched the following electronic bibliographic databases: the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 3), MEDLINE Ovid (1946 to April week 3, 2014), EMBASE Ovid (1980 to 2014 week 17) and PsycINFO Ovid (1987 to April week 4, 2014). We additionally handsearched the trial databases of the most relevant national, international and pharmaceutical company trial registers and drug-approving agencies for published, unpublished and ongoing controlled trials., Selection Criteria: We included RCTs allocating adults (18 years or above) with any primary diagnosis of cancer and depression (including major depressive disorder, adjustment disorder, dysthymic disorder or depressive symptoms in the absence of a formal diagnosis) comparing antidepressants versus placebo, or antidepressants versus other antidepressants., Data Collection and Analysis: Two review authors independently checked eligibility and extracted data using a form specifically designed for the aims of this review. The two authors compared the data extracted and then entered data into RevMan 5 with a double-entry procedure. Information extracted included study and participant characteristics, intervention details, outcome measures for each time point of interest, cost analysis and sponsorship by a drug company. We used the standard methodological procedures expected by The Cochrane Collaboration., Main Results: We retrieved a total of nine studies (861 participants), with seven studies contributing to the meta-analysis for the primary outcome. Four of these compared antidepressants and placebo, two compared two antidepressants and one-three armed study compared two antidepressants and a placebo arm. For the acute phase treatment response (6 to 12 weeks), we found very low quality evidence for the effect of antidepressants as a class on symptoms of depression compared with placebo when measured as a continuous outcome (standardised mean difference (SMD) -0.45, 95% confidence interval (CI) -1.01 to 0.11, five RCTs, 266 participants) or as a proportion of people who had depression (risk ratio (RR) 0.82, 95% CI 0.62 to 1.08, five RCTs, 417 participants). No trials reported data on the follow-up response (more than 12 weeks). In head-to-head comparisons we only retrieved data for selective serotonin reuptake inhibitors (SSRIs) versus tricyclic antidepressants, providing very low quality evidence for the difference between these two classes (SMD -0.08, 95% CI -0.34 to 0.18, three RCTs, 237 participants). No clear evidence of an effect of antidepressants versus either placebo or other antidepressants emerged from the analyses of the secondary efficacy outcomes (dichotomous outcome, response at 6 to 12 weeks, very low quality evidence). We found very low quality evidence for the effect of antidepressants as a class in terms of dropouts due to any cause compared with placebo (RR 0.87, 95% CI 0.49 to 1.53, six RCTs, 455 participants), as well as between SSRIs and tricyclic antidepressants (RR 0.83, 95% CI 0.53 to 1.30, three RCTs, 237 participants). We downgraded the quality of the evidence because the included studies were at an unclear or high risk of bias due to poor reporting, imprecision arising from small sample sizes and wide confidence intervals, and inconsistency due to statistical or clinical heterogeneity., Authors' Conclusions: Despite the impact of depression on people with cancer, available studies were very few and of low quality. This review found very low quality evidence for the effects of these drugs compared with placebo. On the basis of these results clear implications for practice cannot be made. The use of antidepressants in people with cancer should be considered on an individual basis and, considering the lack of head-to-head data, the choice of which agent should be prescribed may be based on the data on antidepressant efficacy in the general population of individuals with major depression, also taking into account that data on medically ill patients suggest a positive safety profile for the SSRIs. Large, simple, randomised, pragmatic trials comparing commonly used antidepressants versus placebo in people with cancer with depressive symptoms, with or without a formal diagnosis of a depressive disorder, are urgently needed to better inform clinical practice.

Introduction: In recent years the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology has often been used by international or national health authorities, or scientific societies, for developing evidence-based treatment recommendations. However, the GRADE approach has never been used by practicing physicians who aim at harmonizing their prescribing behaviours paying due attention to the best available evidence. This paper describes the experience of a working group of psychiatrists who adopted the GRADE approach to develop clinical recommendations on the use of psychotropic drugs in specialist mental healthcare., Case Description: The project was conducted in the Department of Mental Health of Verona, Italy, a city located in the north of Italy. At the beginning of 2012, psychiatrists with a specific interest in the rational use of psychotropic drugs were identified and appointed as members of a Guideline Development Group (GDG). The first task of the GDG was the identification of controversial areas in the use of psychotropic drugs, the definition of scoping questions, and the identification of outcomes of interest. The GDG was supported by a scientific secretariat, who searched the evidence, identified one or more systematic reviews matching the scoping questions, and drafted GRADE tables., Discussion and Evaluation: On the basis of efficacy, acceptability, tolerability and safety data, considering the risk of bias and confidence in estimates, and taking also into consideration preferences, values and practical aspects in favour and against the intervention under scrutiny, a draft recommendation with its strength was formulated and agreed by GDG members. Recommendations were submitted for consideration to all specialists of the Department, discussed in two plenary sessions open to the whole staff, and finally approved at the end of 2012., Conclusion: The present project of guideline development raised several challenging and innovating aspects, including a "bottom-up" approach, as it was motivated by reasons that found agreement among specialists, those who developed the recommendations were those who were supposed to follow them, and values, preferences and feasibility issues were considered paying due attention to local context variables.

Aims: Almost no data are available on whether patients and doctors have similar or dissimilar opinions on the presence and level of distress due to antipsychotic adverse effects. The aim of this survey is to compare doctors' versus patients' perspective on the presence and level of distress due to antipsychotic adverse effects in a sample of patients under the care of the South-Verona mental health services., Methods: All patients exposed to antipsychotic drugs during a census period of 6 months were identified. For each included subject, socio-demographic, clinical and treatment data were extracted. Patients' perspective on antipsychotic adverse effects was measured by means of the Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS). The LUNSERS was similarly employed to measure doctors' perspective on antipsychotic adverse effects., Results: During the recruitment period, 243 patients taking antipsychotic drugs were enrolled. The correlation between the total LUNSERS score reported by patients and doctors was very low (correlation coefficient 0.22, 95% confidence interval 0.15-0.30). On average, patients perceived more adverse effects and with a significant higher distress than doctors. Multivariate analyses found no factors simultaneously associated with both patient and doctor ratings of adverse effects., Conclusion: Our study suggests that doctors, researchers and health care providers should increasingly consider patient and doctor perspectives as two complementary dimensions that may provide different insights in the evaluation of antipsychotic drugs. Integrating different points of view may represent a way to develop a better therapeutic alliance that might decrease the likelihood of nonadherence.