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Introduction: Since its first publication in 1977, the World Health Organization's (WHO) Model List of Essential Medicines (EML) has guided the national procurement of medicines deemed essential to inform public health policy worldwide. Aiming to include the most effective, safe, and cost-effective medicines for priority conditions, WHO updates the EML every two years. However, over the past 45 years, updates to the mental health section of the EML have been infrequent, mostly involving the addition of individual medicines. A comprehensive revision of the entire section was never attempted. Objectives: The aim of this project was to update the mental health section of the EML to identify the most effective and safest medicines for mental disorders in the light of the most up-to-date evidence base. Methods: A series of nine evidence-based applications were submitted to the WHO Expert Committee on the Selection and Use of Essential Medicines in December 2022, recommending a substantial revision of the entire mental health section. Results: All of our applications were accepted by the WHO Expert Committee. For psychotic disorders, aripiprazole, olanzapine, paliperidone, and quetiapine were added as therapeutic alternatives to risperidone; short-acting intramuscular chlorpromazine was replaced by short-acting intramuscular olanzapine; first-generation antipsychotics were limited to oral haloperidol and chlorpromazine. For bipolar disorder, the list now includes second-generation antipsychotics such as quetiapine, aripiprazole, olanzapine, and paliperidone. Tricyclic antidepressants for depressive disorders were limited to amitriptyline alone. Treatment options for anxiety and obsessive-compulsive disorder are now expanded to include SSRIs. For anxiety disorders, diazepam and lorazepam became the only benzodiazepines recommended, with the specific caveat that they should only be used for short-term emergency treatment of acute and severe anxiety symptoms. Finally, chlorpromazine and haloperidol are no longer considered essential medications for psychotic disorders in children under 13 years of age. Conclusions: The WHO released the 23rd EML in July 2023. After decades of minimal and inconsistent updates, groundbreaking changes have been made to its mental health section. The updated mental health section provides a compelling opportunity to improve the quality of medicine selection at the country level, with the goal of increasing the availability of the safest and most effective psychotropic medicines worldwide. Disclosure of Interest: None Declared [ABSTRACT FROM AUTHOR]

Introduction: Generalized anxiety disorder (GAD) is one of the most common mental disorders in adults. Psychotherapies are among the most recommended treatment choices for GAD, but which should be considered as first-line treatment still needs to be clarified. Objectives: To examine the most effective and accepted psychotherapy for GAD both in the short and long-term, via a network meta-analysis. Methods: We searched MEDLINE, Embase, PsycINFO, and the Cochrane Register of Controlled Trials – CENTRAL, from database inception to January 1st, 2023, to find randomized controlled trials (RCTs) of psychotherapies for GAD. Eight psychotherapies (behaviour therapy, cognitive-behaviour therapy, cognitive restructuring, psychoeducation, psychodynamic therapy, relaxation therapy, supportive psychotherapy, and third-wave CBTs) were compared with each other and two control conditions (treatment as usual, waiting list). We followed Cochrane standards when extracting data and assessing data quality and used PRISMA guidelines for the reporting. We conducted random-effects model pairwise and network meta-analyses. We assessed risk of bias of individual studies through the second version of the Cochrane's Risk of Bias tool and used the Confidence in Network Meta-Analysis (CINeMA) to rate certainty of evidence for meta-analytical results. Severity of GAD symptoms and acceptability of the psychotherapies were our outcomes of interest. Results: We analysed data from 66 RCTs. Effect size estimates on data from 5,597 participants suggest third wave cognitive-behavioural therapies (standardized mean differences [SMDs] =-0.78; 95%CI=-1.19 to -0.37; certainty=moderate), cognitive-behavioural therapy (CBT) (SMD=-0.68; 95%CI=-1.05 to -0.32 certainty=moderate), and relaxation therapy (SMD=-0.54; 95%CI=-1.04 to -0.05; certainty=low) reduced generalized anxiety symptoms more than treatment as usual (TAU). Relative risks for all-cause discontinuation signalled no differences compared with TAU for all psychotherapies. When excluding studies at high risk of bias, relaxation therapy lost its superiority over TAU. When considering anxiety severity at three to twelve months after completion of the intervention only CBT remained significantly more efficacious than TAU (SMD=-0.58; 95%CI=-0.93 to -0.23). Image: Conclusions: Given the evidence for both acute and long-term efficacy, CBT may represent the reasonable first-line psychological treatment for GAD. Third-wave CBT and relaxation therapy have short-term efficacy and may also be offered. Results from this investigation should inform patients, clinicians, and guidelines. This project is funded by the European Union's HORIZON EUROPE research programme under grant agreement No 101061648. Disclosure of Interest: None Declared [ABSTRACT FROM AUTHOR]

Introduction: The global burden associated with common mental disorders is high, especially for people living in low resource settings. Although psychosocial interventions delivered by locally available lay or community health workers are effective, mechanisms of intervention response are poorly understood. One of the greatest barriers is that psychosocial interventions are administered as complex, multi-component "packages of care". Objectives: Our aim is to systematically review all the randomized controlled trials (RCTs) that have tested the efficacy of psychosocial interventions delivered through the task shifting modality to treat people suffering from common mental disorders (depression, anxiety, and related somatic complaints) in low resource settings, dismantle the intervention protocols creating a taxonomy of active intervention components, and re-evaluate their efficacy. Methods: We will use the component network meta-analysis (cNMA) methodology. The major benefit of cNMA is the possibility to disentangle intervention components and explore their effectiveness separately or in various combinations (even in disconnected networks). cNMA increases statistical power by combining direct and indirect comparisons while fully respecting the randomized structure of the evidence. According to the additive cNMA model which we will implement, adding a component "c" to a composite intervention "X" will lead to an increase (or decrease) of the effect size by an amount only dependent on "c", and not on "X". We will denote the corresponding component specific incremental standard mean difference (iSMD) so that iSMDc = SMD(X+c) v. (X). Combining these component-specific iSMDs will allow the estimation of SMD between any two composite interventions. Results: A network of comparisons and a hierarchy that includes all intervention components expressed as iSMD, indicating the added benefit of adding a component to an intervention, will be presented. By selecting the most effective components it will be possible to outline a novel task shifting psychosocial intervention to be tested in future RCTs. Conclusions: These findings will set the basis for further investigations in the field of precision medicine. This project is funded by the European Union's HORIZON EUROPE research programme under grant agreement No 101061648. Disclosure of Interest: None Declared [ABSTRACT FROM AUTHOR]

Introduction: The transition phase from late adolescence to early adulthood, which corresponds with the period of university life, is a time that offers important opportunities for personal growth. However, this developmental phase also concurs with the peak period of risk for the onset of mental health disorders. For this reason, the literature clearly identifies university students as a vulnerable population group for psychogical distress and mental problems. Digital psychological interventions and e-mental health solutions are emerging as a promising solution for university students, particularly appealing due to their anonymity, portability and ease of access. Hence, the World Health Organisation has developed several psychosocial e-mental health tools including Doing What Matters in Times of Stress (DWM), which has been consistently shown effective in various vulnerable populations. These data provide the framework for the CAMPUS study that is intended for students attending the University of Verona. Objectives: The main objective of this project is to adapt the WHO psychological intervention called "Doing What Matters in Times of Stress" (DWM) to this target population and to evaluate the effectiveness, feasibility, and acceptability of WHO's DWM as a psychological strategy for effective mental health prevention and promotion, and for reducing psychological symptoms and distress in university students. Secondary objectives of the project include to evaluate the fidelity of DWM, to assess factors associated with its implementation and effectiveness and to co-create the necessary local conditions for implementation and up-scaling of DWM. Methods: The CAMPUS study is a prospective non-randomized follow-up study. The target population is composed by university students of University of Verona, Italy. The online assessments, which are collected pre and post intervention, consist of an ad-hoc sociodemographic information page, and four self-administered questionnaires assessing psychological distress, depression and anxiety symptoms, and psychological well-being. In addition, implementation checklists will be administered to assess the acceptability, appropriateness and feasibility of the intervention. Results: Preliminary results on a sample of 300 students attending University of Verona show that the adapted DWM intervention promote students' psychological well-being and reduce the level of psychological distress as well as the risk for the later development of a psychopathology. Moreover we expect that future results would include data on the effectiveness, feasibility, and acceptability of the adapted DWM intervention among university students Conclusions: These results provide valuable information for mental health promotion and support programs for university students, as well as insights into factors influencing its implementation and suggestions for future scaling of the intervention. Disclosure of Interest: None Declared [ABSTRACT FROM AUTHOR]

Introduction: 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. Objectives: 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). Methods: 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-seriousAEs using non-parametrical tests. Results: The FAERS database registered 962 reports of esketaminerelated 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. Conclusions: 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. [ABSTRACT FROM AUTHOR]