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Background: In asylum seekers and refugees, the frequency of mental disorders, such as depression, anxiety and post-traumatic stress disorder, is higher than the general population, but there is a lack of data on risk factors for the development of mental disorders in this population., Aim: This study investigated the risk factors for mental disorder development in a large group of asylum seekers and refugees resettled in high- and middle-income settings., Methods: Participant-level data from two randomized prevention studies involving asylum seekers and refugees resettled in Western European countries and in Turkey were pooled. The two studies randomized participants with psychological distress, but without a diagnosis of mental disorder, to the Self-Help Plus psychological intervention or enhanced care as usual. At baseline, exposure to potentially traumatic events was measured using the Harvard Trauma Questionnaire-part I, while psychological distress and depressive symptoms were assessed with the General Health Questionnaire and the Patient Health Questionnaire. After 3 and 6 months of follow-up, the proportion of participants who developed a mental disorder was calculated using the Mini International Neuropsychiatric Interview., Results: A total of 1,101 participants were included in the analysis. At 3- and 6-month follow-up the observed frequency of mental disorders was 13.51% (115/851) and 24.30% (207/852), respectively, while the frequency estimates after missing data imputation were 13.95% and 23.78%, respectively. After controlling for confounders, logistic regression analysis showed that participants with a lower education level ( p  = .034), a shorter duration of journey ( p  = .057) and arriving from countries with war-related contexts ( p  = .017), were more at risk of developing mental disorders. Psychological distress ( p  = .004), depression ( p  = .001) and exposure to potentially traumatic events ( p  = .020) were predictors of mental disorder development., Conclusions: This study identified several risk factors for the development of mental disorders in asylum seekers and refugees, some of which may be the target of risk reduction policies. The identification of asylum seekers and refugees at increased risk of mental disorders should guide the implementation of focused preventative psychological interventions.

Background: Longitudinal studies examining mental health trajectories in refugees and asylum seekers are scarce. Objectives: To investigate trajectories of psychological symptoms and wellbeing in refugees and asylum seekers, and identify factors associated with these trajectories. Method: 912 asylum seekers and refugees from the control arm of three trials in Europe ( n  = 229), Turkey ( n  = 320), and Uganda ( n  = 363) were included. We described trajectories of psychological symptoms and wellbeing, and used trauma exposure, age, marital status, education, and individual trial as predictors. Then, we assessed the bidirectional interactions between wellbeing and psychological symptoms, and the effect of each predictor on each outcome controlling for baseline values. Results: Symptom improvement was identified in all trials, and for wellbeing in 64.7% of participants in Europe and Turkey, versus 31.5% in Uganda. In Europe and Turkey domestic violence predicted increased symptoms at post-intervention ( ß  = 1.36, 95% CI 0.17-2.56), whilst murder of family members at 6-month follow-up ( ß  = 1.23, 95% CI 0.27-2.19). Lower wellbeing was predicted by murder of family member ( ß  = -1.69, 95% CI -3.06 to -0.32), having been kidnapped ( ß  = -1.67, 95% CI -3.19 to -0.15), close to death ( ß  =  -1.38, 95% CI -2.70 to -0.06), and being in the host country ≥2 years ( ß  =  -1.60, 95% CI -3.05 to -0.14). In Uganda at post-intervention, having been kidnapped predicted increased symptoms ( ß  = 2.11, 95% CI 0.58-3.65), and lack of shelter ( ß  = -2.51, 95% CI -4.44 to -0.58) and domestic violence predicted lower wellbeing ( ß  = -1.36, 95% CI -2.67 to -0.05). Conclusion: Many participants adapt to adversity, but contextual factors play a critical role in determining mental health trajectories., Competing Interests: No potential conflict of interest was reported by the author(s)., (© 2022 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.)

Aims: As refugees and asylum seekers are at high risk of developing mental disorders, we assessed the effectiveness of Self-Help Plus (SH + ), a psychological intervention developed by the World Health Organization, in reducing the risk of developing any mental disorders at 12-month follow-up in refugees and asylum seekers resettled in Western Europe., Methods: Refugees and asylum seekers with psychological distress (General Health Questionnaire-12 ⩾ 3) but without a mental disorder according to the Mini International Neuropsychiatric Interview (M.I.N.I.) were randomised to either SH + or enhanced treatment as usual (ETAU). The frequency of mental disorders at 12 months was measured with the M.I.N.I., while secondary outcomes included self-identified problems, psychological symptoms and other outcomes., Results: Of 459 participants randomly assigned to SH + or ETAU, 246 accepted to be interviewed at 12 months. No difference in the frequency of any mental disorders was found (relative risk [RR] = 0.841; 95% confidence interval [CI] 0.389-1.819; p -value = 0.659). In the per protocol (PP) population, that is in participants attending at least three group-based sessions, SH + almost halved the frequency of mental disorders at 12 months compared to ETAU, however so few participants and events contributed to this analysis that it yielded a non-significant result (RR = 0.528; 95% CI 0.180-1.544; p -value = 0.230). SH + was associated with improvements at 12 months in psychological distress ( p -value = 0.004), depressive symptoms ( p -value = 0.011) and wellbeing ( p -value = 0.001)., Conclusions: The present study failed to show any long-term preventative effect of SH + in refugees and asylum seekers resettled in Western European countries. Analysis of the PP population and of secondary outcomes provided signals of a potential effect of SH + in the long-term, which would suggest the value of exploring the effects of booster sessions and strategies to increase SH + adherence.

Introduction: Self-Help Plus (SH+) is a group-based psychological intervention developed by the World Health Organization for managing stress., Objective: To assess the effectiveness of SH+ in preventing mental disorders in refugees and asylum seekers in Western Europe., Methods: We conducted a randomized controlled trial in 5 European countries. Refugees and asylum seekers with psychological distress (General Health Questionnaire score ≥3), but without a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) or ICD/10 diagnosis of mental disorder, as assessed with the Mini International Neuropsychiatric Interview (MINI), were randomized to SH+ or enhanced treatment as usual (ETAU). The primary outcome was the frequency of mental disorders with the MINI at 6 months. Secondary outcomes included the frequency of mental disorders at postintervention, self-identified problems, psychological symptoms, and other outcomes., Results: Four hundred fifty-nine individuals were randomly assigned to SH+ or ETAU. For the primary outcome, we found no difference in the frequency of mental disorders at 6 months (Cramer V = 0.007, p = 0.90, RR = 0.96; 95% CI 0.52-1.78), while the difference significantly favored SH+ at after the intervention (secondary outcome, measured within 2 weeks from the last session; Cramer V = 0.13, p = 0.01, RR = 0.50; 95% CI 0.29-0.87)., Conclusions: This is the first randomized indicated prevention study with the aim of preventing the onset of mental disorders in asylum seekers and refugees in Western Europe. As a prevention effect of SH+ was not observed at 6 months, but rather after the intervention only, modalities to maintain its beneficial effect in the long term need to be identified., (© 2021 The Author(s) Published by S. Karger AG, Basel.)

The principle of pragmatism in clinical trials has been broadly recognised as a way to close the gap between research and practice. In this contribution, we argue that the conduct of pragmatic clinical trials in Europe may be hampered by poor implementation of current European Union's Clinical Trial Regulation No. 536/2014.

Introduction: This article describes two randomised controlled trials that will evaluate the effectiveness and cost-effectiveness of Self-Help Plus (SH+), a group self-help intervention developed by the WHO to reduce distress. In these trials SH+ is being tested as a preventative intervention to lower the incidence of mental disorders in asylum seekers and refugees with psychological distress resettled in Europe and Turkey., Methods and Analysis: Two prospective, multicentre, randomised, rater-blinded, parallel-group studies will follow participants over a period of 12 months. One trial will be conducted in Europe and one in Turkey. In each trial, 600 asylum seekers and refugees screening positive on the General Health Questionnaire (≥3), but without a formal diagnosis of any mental disorders according to the Mini International Neuropsychiatric Interview, will be randomly allocated to SH+or to enhanced treatment-as-usual. The primary outcome will be a lower incidence of mental disorders at 6 month follow-up. Secondary outcomes will include the evaluation of psychological symptoms, functioning, well-being, treatment acceptability and indicators of intervention cost-effectiveness., Ethics and Dissemination: The two trials received ethical clearance from the local Ethics Committees of the participating sites (seven sites), as well as from the WHO Ethics Committee. All participants will provide informed consent before screening and before study inclusion (a two-step procedure). The results of the trials will be disseminated in agreement with a dissemination plan that includes publication(s) in peer-reviewed journals and presentations at relevant national and international conferences and meetings., Trials Registration Numbers: NCT03571347, NCT03587896., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Background: Antipsychotics (APs) have been associated with risk of torsade de Pointes (TdP). This has important public health implications. Therefore, (a) we exploited the public FDA Adverse Event Reporting System (FAERS) to characterize their torsadogenic profile; (b) we collected drug utilization data from 12 European Countries to assess the population exposure over the 2005-2010 period., Methods: FAERS data (2004-2010) were analyzed based on the following criteria: (1) ≥ 4 cases of TdP/QT abnormalities; (2) Significant Reporting Odds Ratio, ROR [Lower Limit of the 95% confidence interval>1], for TdP/QT abnormalities, adjusted and stratified (Arizona CERT drugs as effect modifiers); (3) ≥ 4 cases of ventricular arrhythmia/sudden cardiac death (VA/SCD); (4) Significant ROR for VA/SCD; (5) Significant ROR, combined by aggregating TdP/QT abnormalities with VA and SCD. Torsadogenic signals were characterized in terms of signal strength: from Group A (very strong torsadogenic signal: all criteria fulfilled) to group E (unclear/uncertain signal: only 2/5 criteria). Consumption data were retrieved from 12 European Countries and expressed as defined daily doses per 1,000 inhabitants per day (DID)., Results: Thirty-five antipsychotics met at least one criterium: 9 agents were classified in Group A (amisulpride, chlorpromazine, clozapine, cyamemazine, haloperidol, olanzapine, quetiapine, risperidone, ziprasidone). In 2010, the overall exposure to antipsychotics varied from 5.94 DID (Estonia) to 13.99 (France, 2009). Considerable increment of Group A agents was found in several Countries (+3.47 in France): the exposure to olanzapine increased across all Countries (+1.84 in France) and peaked 2.96 in Norway; cyamemazine was typically used only in France (2.81 in 2009). Among Group B drugs, levomepromazine peaked 3.78 (Serbia); fluphenazine 1.61 (Slovenia)., Conclusions: This parallel approach through spontaneous reporting and drug utilization analyses highlighted drug- and Country-specific scenarios requiring potential regulatory consideration: levomepromazine (Serbia), fluphenazine (Slovenia), olanzapine (across Europe), cyamemazine (France). This synergy should be encouraged to support future pharmacovigilance activities.

Corrado Barbui and Irene Bighelli question the current rules governing registration of new medicines in Europe, using the example of psychiatric drugs, and argue that the concept of absolute efficacy should be replaced by the concept of added value whereby evidence from studies comparing a new product with an active comparator should guide the drug approval process. Please see later in the article for the Editors' Summary.

In Europe, new medicines are approved or rejected on the basis of the results of studies carried out by the manufacturer and submitted to the European Medicines Agency (EMA). This article briefly presents the main roles and responsibilities of the EMA and the key rules that govern the approval process. The main scientific limitations of this process are highlighted, together with some suggestions for dealing with them.

Aim: To investigate the relation between medication-related factors and adherence in people with schizophrenia in outpatient treatment., Methods: The sample comprised 409 outpatients (ICD-10 diagnosis of schizophrenia) with clinician-rated instability in four European cities (Amsterdam, The Netherlands; Verona, Italy; Leipzig, Germany; London, Great Britain). Adherence was assessed using the Medication Adherence Questionnaire (patient perspective), and the Clinician Rating Scale (clinician perspective). Examined medication-related factors were type (atypical vs. typical), application (oral vs. depot), daily dose frequency of antipsychotic medication (Medication History Scale), number of side effects (Liverpool University Neuroleptic Side Effect Rating Scale), and patient attitudes toward medication (Drug Attitude Inventory). Multiple regression analysis was used to identify predictors of adherence by medication-related factors., Results: Adherence, as rated by patient and clinician, was predicted by patient attitude towards medication, but was unrelated to type of drug, formulation or side effects of antipsychotic medication. A high daily dose frequency was associated with better adherence, but only when rated by the patient., Conclusions: In order to improve adherence there is a need to seriously consider and attempt to improve patient attitude toward medication. However, type of antipsychotic and other medication-related factors may not be as closely related to adherence as it has often been suggested.

Background: Factors influencing patient and clinician perspectives in the assessment of medication adherence have never been compared., Method: This study used baseline and 12-month follow-up data from the QUATRO study, an international multicentre study. At baseline, information on patient sociodemographic characteristics, treatment factors, psychopathology, functioning and experience of antipsychotic side effects was gathered. After 12 months of follow-up, psychopathology, functioning and patient experience of antipsychotic side effects were measured once more, and a patient and clinician rating of adherence was obtained by means of the Medication Adherence Rating Scale (MARS) and the Compliance Rating Scale (CRS)., Results: During the recruitment period, 409 subjects with a diagnosis of schizophrenia were recruited. Patients were more often men and single. Mean age was 41.5 years. At the time of the assessment, more than 40% were unemployed and on average had been on antipsychotic treatment for more than 10 years. Nearly 70% were receiving second-generation antipsychotics, and 50% received adherence therapy during the 12 months after enrollment. The relationship between the MARS and the CRS scores showed only a small overlap (correlation coefficient = 0.26). In the multivariate model, the only factor significantly associated with both patient and clinician ratings of adherence was psychopathology. Unemployment and poor subjective tolerability of antipsychotics were significantly associated with low levels of patient ratings of adherence. Conversely, length of treatments and use of newer antipsychotics were significantly associated with better clinician ratings of adherence., Conclusion: Patient and clinician ratings of adherence do not measure the same dimension. Factors that may positively affect adherence in terms of compliance with prescribed medication regimens may not affect patients' views on adherence, and this should be taken into consideration when planning and negotiating treatment modalities with each individual patient suffering from schizophrenia.

The present study investigated the use of antipsychotics in a sample of clinically unstable patients with schizophrenia who were recruited in four European sites. The study aimed: (i) to test whether the length of previous antipsychotic exposure was associated with the choice of antipsychotic medication; (ii) to test whether the severity of illness was associated with the use of second-generation antipsychotic agents (SGAs) or with the concomitant use of both first-generation antipsychotics (FGAs) and SGAs; and (iii) to investigate differences between study sites. Participants were recruited from patients under the care of psychiatric services serving geographical catchment areas in Croydon (UK), Verona (Italy), Amsterdam (The Netherlands) and Leipzig (Germany). Clinically unstable patients with a clinical diagnosis of schizophrenia and a research diagnosis of schizophrenia, established using the Item Group Checklist of the Schedule for Clinical Assessment in Neuropsychiatry, were enrolled. Sociodemographic and clinical data, including current antipsychotic drug therapy, psychopathology, adherence, insight, side-effects, attitudes towards medication and quality of life, were gathered. Three hundred and ninety patients were analysed in total. Almost 60% received SGAs, less than one-third FGAs, and less than 15% received both drug classes. Those receiving SGAs were younger and with a shorter length of antipsychotic drug therapy, whereas those receiving both drug classes were more often separated or widowed, unemployed and with a long history of antipsychotic drug therapy. The distribution of patients receiving FGAs, SGAs and both drug classes by illness-related variables showed that patients receiving both drug classes were more severely ill and complained of more side-effects. Using patients receiving FGAs as the reference category, multinomial logistic regression analysis showed that the length of antipsychotic treatment was negatively correlated with receiving SGAs, and that the severity of illness and being separated/widowed were positively correlated with receiving both drug classes. Compared with patients in Leipzig, patients in Amsterdam, Croydon and Verona were less frequently treated with SGAs and with combinations of both drug classes. Consistent with current clinical uncertainty with respect to what pharmacological treatment should be provided, patients with a long history of antipsychotic exposure were receiving FGAs, SGAs and combinations of both drug classes. Physicians tended to reserve polypharmacy for difficult-to-treat patients (i.e. for managing situations where, despite the lack of an evidence base, there is a pressing need to provide clinical answers).