Evidence on neonatal withdrawal syndrome following antidepressant intrauterine exposure is limited, particularly for antidepressants other than selective serotonin reuptake inhibitor (SSRIs).

In our case/non-case pharmacovigilance study, based on VigiBase®, the WHO database of suspected adverse drug reactions, we estimated reporting odds ratio (ROR) and the Bayesian information component (IC) with 95% confidence/credibility intervals (CI) as measures of disproportionate reporting of antidepressant-related neonatal withdrawal syndrome. Antidepressants were first compared to all other medications, then to methadone, and finally within each class of antidepressants: SSRIs, tricyclics (TCA) and other antidepressants. Antidepressants were ranked in terms of clinical priority, based on semiquantitative score ratings. Serious v. non-serious reports were compared.

A total of 406 reports of neonatal withdrawal syndrome in 379 neonates related to 15 antidepressants were included. Disproportionate reporting was detected for antidepressants as a group as compared to all other drugs (ROR: 6.18, 95% CI 5.45–7.01, IC: 2.07, 95% CI 1.92–2.21). Signals were found for TCAs (10.55, 95% CI 8.02–13.88), followed by other antidepressants (ROR: 5.90, 95% CI 4.74–7.36) and SSRIs (ROR: 4.68, 95% CI 4.04–5.42). Significant disproportionality emerged for all individual antidepressants except for bupropion, whereas no disproportionality for any antidepressant was detected v. methadone. Eleven antidepressants had a moderate clinical priority score and four had a weak one. Most frequent symptoms included respiratory symptoms (n = 106), irritability/agitation (n = 75), tremor (n = 52) and feeding problems (n = 40).

Most antidepressants are associated with moderate signals of disproportionate reporting for neonatal withdrawal syndrome, which should be considered when prescribing an antidepressant during pregnancy, irrespective of class.

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.

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.

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).

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.

To provide a cross-country analysis of selection, availability, prices and affordability of essential medicines for mental health conditions, aiming to identify areas for improvement.

We used the World Health Organization (WHO) online repository of national essential medicines lists (EMLs) to extract information on the inclusion of essential psychotropic medicines within each country's EML. Data on psychotropic medicine availability, price and affordability were obtained from the Health Action International global database. Additional information on country availability, prices and affordability of essential medicines for mental disorders was identified by searching, up to January 2021, PubMed/Medline, CINAHIL, Scopus and the WHO Regional Databases. We summarised and compared the indicators across lowest-price generic and originator brand medicines in the public and private sectors, and by country income groups.

A total of 112 national EMLs were analysed, and data on psychotropic medicine availability, price and affordability were obtained from 87 surveys. While some WHO essential psychotropic medicines, such as chlorpromazine, haloperidol, amitriptyline, carbamazepine and diazepam, were selected by most national lists, irrespective of the country income level, other essential medicines, such as risperidone or clozapine, were included by most national lists in high-income countries, but only by a minority of lists in low-income countries. Up to 40% of low-income countries did not include medicines that have been in the WHO list for decades, such as long-acting fluphenazine, lithium carbonate and clomipramine. The availability of generic and originator psychotropic medicines in the public sector was below 50% for all medicines, with low-income countries showing rates lower than the overall average. Analysis of price data revealed that procurement prices were lower than patient prices in the public sector, and medicines in the private sector were associated with the highest prices. In low-income countries, the average patient price for amitriptyline and fluoxetine was three times the international unit reference price, while the average patient price for diazepam was ten times the international unit reference price. Affordability was higher in the public than the private sector, and in high-income than low-income countries.

Access to medicines for mental health conditions is an ongoing challenge for health systems worldwide, and no countries can claim to be fully aligned with the general principle of providing full access to essential psychotropic medicines. Low availability and high costs are major barriers to the use of and adherence to essential psychotropic medicines, particularly in low-and middle-income countries.

The approval of the esketamine nasal spray for treatment-resistant depression in March 2019 by the Food and Drug Administration (FDA), and few months later by the European Medicine Agency, triggered a vivid debate and many concerns, mainly because of the lack of convincing evidence on its efficacy and safety, based on the development programs, approval trials and few post-marketing trials.

We aimed to detect and characterize safety signals for esketamine, by analyzing relevant adverse events (AEs) reports in the FDA Adverse Event Reporting System (FAERS) database (March 2019-March 2020).

We performed disproportionality analysis through the case/non-case approach: reporting odds ratios (ROR) and information components (IC) with 95% confidence intervals (95%CI) were estimated for esketamine-related AEs with at least four counts. We compared serious and non-serious AEs using non-parametrical tests.

The FAERS database registered 962 reports of esketamine-related AEs in one year. Signals (i.e., statistically significant disproportionality) were detected for several AEs, such as dissociation, sedation, feeling drunk, suicidal ideation and completed suicide. Signals for suicidal ideation, but not suicide attempt and completed suicide, remained significant when comparing esketamine to venlafaxine. The comparison of patients with serious vs. non-serious esketamine AEs revealed that females, patients receiving antidepressant polypharmacy, co-medication with antipsychotics, mood stabilizers, benzodiazepines or somatic medications were more likely to suffer from serious AEs.

This real-world pharmacovigilance analysis detected signals of serious unexpected esketamine-related AEs, thus reinforcing current worries regarding esketamine safety/acceptability. Further real-world studies are urgently needed to unravel the safety profile of esketamine.

No significant relationships.

People with coronavirus disease (COVID-19) may frequently require treatment with psychotropic medications, but the underlying medical condition and possible interaction with medical treatments might pose serious safety issues.

To review the direct and indirect evidence on the safety of psychotropic drugs in people with COVID-19 and provide practical recommendations for frontline clinicians.

An international, multi-disciplinary working group was established with the aim of producing evidence-based recommendations on the management of psychotropic medications in people with COVID-19, following the WHO Rapid Advice Guidelines methodology in the context of a public health emergency. Evidence retrieved was focused on the risk of respiratory, cardiovascular, infective, hemostatic, and consciousness alterations related to the use of psychotropic medications. Furthermore, drug-drug interactions between psychotropic and medical treatments used in people with COVID-19 was reviewed and critically discussed by the working group.

The analysis of available evidence, although indirect, showed that all classes of psychotropic medications might carry relevant safety risks for people with COVID-19. The working group produced a set of 12 recommendations to support clinicians in the assessment of the anticipated risk of psychotropic-related unfavourable events, and how to practically manage this risk, including when it is appropriate to avoid, withdraw, switch, or adjust the dose of the medication.

The present evidence-based recommendations will improve the quality of psychiatric care in people with COVID-19, allowing an appropriate management of the medical condition without worsening the psychiatric condition and vice versa.

No significant relationships.

Panic disorder is among the most prevalent anxiety diseases. Although psychotherapy is recommended as first-line treatment for panic disorder, little is known about the relative efficacy of different types of psychotherapies.

To evaluate the effectiveness and acceptability of different types of psychotherapies for adults suffering from panic disorder, with or without agoraphobia.

We are conducting a systematic network meta-analysis of randomized controlled trials examining panic disorder. A comprehensive search was performed to identify relevant studies. The primary efficacy outcome is anxiety symptoms at study endpoint. The primary acceptability outcome is all-cause trial discontinuation at endpoint. Pairwise and network meta-analysis will be conducted. We are considering any kind of psychotherapy delivered by any therapist, as long as they were trained to deliver the therapy, or as self-help.

To date we have identified 126 panic disorder and agoraphobia trials. The publication time span ranges from 1968 to 2020. We are now extracting data to provide an overview of the included study characteristics. The statistical analysis will be conducted between December 2020 and January 2021, and its results presented for the first time at the forthcoming 2021 EPA congress.

126 trials on psychotherapy for panic disorders in adults are available. Because of this huge body of knowledge, it is important that the results of these studies are summarized using network meta-analytic techniques. The findings of this study will guide future research as knowledge gaps will be easily identified. Moreover, policymakers will have the opportunity to use this summarized knowledge to inform evidence-based decision making.

No significant relationships.

To develop recommendations for strategies and interventions to reduce stigma and discrimination related to coronavirus disease 2019 (COVID-19), through reviewing and synthesising evidence in relation to COVID-19 and other disease outbreaks and infectious/stigmatised conditions from systematic reviews and primary studies and recommendations from additional materials.

Rapid review, drawing on the World Health Organization's (WHO) methodology for developing interim guidelines during health emergencies. PubMed/MEDLINE, PsycINFO, Cochrane Central and Campbell Collaboration searched up to mid-April 2020. Searches were supplemented by reference-searching and expert recommendations. Searches were designed to identify: (1) systematic reviews (<10 years), or (2) primary intervention studies (no date limit) reporting evidence on anti-stigma interventions (in relation to COVID-19 or other infectious/stigmatised conditions) or (3) additional relevant materials. Data were extracted on population, intervention, outcome and results. These data were compiled into evidence summary tables and narrative overviews. Recommendations on strategies for COVID-19 stigma-reduction were developed using the WHO ‘Evidence to Decision’ framework approach. The review protocol was registered with PROSPERO (registration ID: CRD42020177677).

The searches identified a total of 4150 potentially relevant records, from which 12 systematic reviews and 29 additional articles were included. Overarching considerations and specific recommendations focus on: (1) language/words used in relation to COVID-19 and affected people; (2) media/journalistic practices; (3) public health interventions; (4) targeted public health interventions for key groups and (5) involving communities and key stakeholders.

These recommendations represent the first consolidated evidence-based guidance on stigma and discrimination reduction in relation to COVID-19. Mitigating the impact of stigma is critical in reducing distress and negative experiences, and strengthening communities' resolve to work together during exceptional circumstances. Ultimately, reducing stigma helps addressing structural inequalities that drive marginalisation and exacerbate both health risks and the impact of stigma. Administrations and decision makers are urged to consider integrating these recommendations into the ongoing COVID-19 response.

Observational studies have shown a relationship between maternal mental health (MMH) and child development, but few studies have evaluated whether MMH interventions improve child-related outcomes, particularly in low- and middle-income countries. The objective of this review is to synthesise findings on the effectiveness of MMH interventions to improve child-related outcomes in low- and middle-income countries (LMICs).

We searched for randomised controlled trials conducted in LMICs evaluating interventions with a MMH component and reporting children's outcomes. Meta-analysis was performed on outcomes included in at least two trials.

We identified 21 trials with 28 284 mother–child dyads. Most trials were conducted in middle-income countries, evaluating home visiting interventions delivered by general health workers, starting in the third trimester of pregnancy. Only ten trials described acceptable methods for blinding outcome assessors. Four trials showed high risk of bias in at least two of the seven domains assessed in this review. Narrative synthesis showed promising but inconclusive findings for child-related outcomes. Meta-analysis identified a sizeable impact of interventions on exclusive breastfeeding (risk ratio = 1.39, 95% confidence interval (CI): 1.13–1.71, ten trials, N = 4749 mother–child dyads, I2 = 61%) and a small effect on child height-for-age at 6-months (std. mean difference = 0.13, 95% CI: 0.02–0.24, three trials, N = 1388, I2 = 0%). Meta-analyses did not identify intervention benefits for child cognitive and other growth outcomes; however, few trials measured these outcomes.

These findings support the importance of MMH to improve child-related outcomes in LMICs, particularly exclusive breastfeeding. Given, the small number of trials and methodological limitations, more rigorous trials should be conducted.

QTc interval prolongation is considered a risk factor for fatal polymorphic ventricular tachycardia, which can result in sudden cardiac death. Most psychotropic drugs have a dose-dependent potential to prolong the QTc interval. However, other factors require appropriate consideration, including: age; gender; other medications; electrolyte abnormalities; severe comorbid conditions, such as co-occurring alcohol or substances abuse/dependence.

The objective was to study the potential mediating roles of alcohol/substances abuse on QTc prolongation.

The Italian research group STAR Network, in collaboration with the Young Italian Psychiatrists Association, aimed to evaluate the frequency of QTc interval prolongation in a sample of patients under treatment with psychotropic drugs through a cross-sectional national survey.

A sample of 2411 unselected patients were enrolled after performing an ECG during the recruitment period. Sociodemographic and clinical characteristics were collected from medical records. Collected data underwent statistical analysis.

A total of 11.2% of patients reported alcohol abuse, and only 8.9% psychotropic substances. According to the threshold, less than 20% of patients had a borderline value of QTc, and 1% a pathological value. Patients with co-occurring alcohol misuse and drug abuse were more likely to have longer QTc interval.

The present study describes the frequency of QTc prolongation in real-world clinical practice. Before prescribing a psychotropic drug, the physician should carefully assess its risks and benefits to avoid this type of adverse reaction, particularly when additional risk factors are present. The potential role of alcohol and substances on QTc length could be particularly useful in emergency settings.

The authors have not supplied their declaration of competing interest.

In the past few years, there has been an unprecedented increase in the number of forcibly displaced migrants worldwide, of which a substantial proportion is refugees and asylum seekers. Refugees and asylum seekers may experience high levels of psychological distress, and show high rates of mental health conditions. It is therefore timely and particularly relevant to assess whether current evidence supports the provision of psychosocial interventions for this population. We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) assessing the efficacy and acceptability of psychosocial interventions compared with control conditions (treatment as usual/no treatment, waiting list, psychological placebo) aimed at reducing mental health problems in distressed refugees and asylum seekers.

We used Cochrane procedures for conducting a systematic review and meta-analysis of RCTs. We searched for published and unpublished RCTs assessing the efficacy and acceptability of psychosocial interventions in adults and children asylum seekers and refugees with psychological distress. Post-traumatic stress disorder (PTSD), depressive and anxiety symptoms at post-intervention were the primary outcomes. Secondary outcomes include: PTSD, depressive and anxiety symptoms at follow-up, functioning, quality of life and dropouts due to any reason.

We included 26 studies with 1959 participants. Meta-analysis of RCTs revealed that psychosocial interventions have a clinically significant beneficial effect on PTSD (standardised mean difference [SMD] = −0.71; 95% confidence interval [CI] −1.01 to −0.41; I2 = 83%; 95% CI 78–88; 20 studies, 1370 participants; moderate quality evidence), depression (SMD = −1.02; 95% CI −1.52 to −0.51; I2 = 89%; 95% CI 82–93; 12 studies, 844 participants; moderate quality evidence) and anxiety outcomes (SMD = −1.05; 95% CI −1.55 to −0.56; I2 = 87%; 95% CI 79–92; 11 studies, 815 participants; moderate quality evidence). This beneficial effect was maintained at 1 month or longer follow-up, which is extremely important for populations exposed to ongoing post-migration stressors. For the other secondary outcomes, we identified a non-significant trend in favour of psychosocial interventions. Most evidence supported interventions based on cognitive behavioural therapies with a trauma-focused component. Limitations of this review include the limited number of studies collected, with a relatively low total number of participants, and the limited available data for positive outcomes like functioning and quality of life.

Considering the epidemiological relevance of psychological distress and mental health conditions in refugees and asylum seekers, and in view of the existing data on the effectiveness of psychosocial interventions, these interventions should be routinely made available as part of the health care of distressed refugees and asylum seekers. Evidence-based guidelines and implementation packages should be developed accordingly.