Lacking biomarkers in psychiatry calls for a valid and reliable assessment of psychopathology across mental disorders that is easy to use, bridges research and clinical care, and that can capture clinician and patient perspectives. Herein we propose, a novel, brief, transdiagnostic tool to assess and visualize symptom severity in different psychiatric disorders. The Transdiagnostic Global Impression - Psychopathology scale (TGI-P) is based on the Clinical Global Impression - Severity scale (CGI-S), which was originally designed to measure global illness severity in one score. The TGI-P covers 10 transdiagnostic symptom domains and similar to the CGI-S, it is rated on a 7-point Likert-scale from 1 (normal) to 7 (extreme). These ten domains include positive symptoms, negative symptoms, manic symptoms, depressive symptoms, addiction symptoms, cognitive symptoms, anxiety symptoms, sleep symptoms, hostility symptoms, and self-harm symptoms. The results are visually presented, thus simplifying the monitoring of symptoms, and facilitating discussion with patients and caregivers. As part of the development process, the TGI-P was surveyed among 36 psychiatrists from 3 countries. Importantly, over 80 % of them was "very positive" or "positive" about the concept of the tool, and most of them (70 %) reported willingness to use it in their everyday practice. Further psychometric development and testing of the TGI-P is underway alongside future TGI scales covering adverse events, functioning and satisfaction.

Background: The aim of the post hoc analysis was to better understand the efficacy and safety of cariprazine in patients with schizophrenia for less than 5 years (early stage) and for more than 15 years (late stage).Methods: Data from three phase II/III randomized, double-blind, placebo-controlled trials with similar design in patients with acute exacerbation of schizophrenia were pooled and patients with early and late stage of schizophrenia were determined. A mixed-effects model for repeated measures approach was applied and least square (LS) mean changes from baseline to week 6 on the Positive and Negative Syndrome Scale (PANSS) total and factor scores were reported. Descriptive statistics were used for safety analyses including treatment emergent adverse events (TEAEs) and discontinuation rates.Results: Overall, 460 patients were identified as being in the early and 414 in the late stage of schizophrenia. The pooled analysis evaluating mean change from baseline to week 6 in the PANSS total score indicated statistically significant difference between cariprazine and placebo in favor of cariprazine in both the early (LS mean difference [LSMD] −7.5 P < .001) and late stage (LSMD −6.7, P < .01) subpopulation. Early stage patients experienced similar amount of TEAEs (CAR 67.3%, PBO 54.1%) as patients in the late stage (CAR 69.6%, PBO 65.6%).Conclusion: In conclusion, cariprazine, a potent D₃-D₂ partial agonist has been found to be safe and effective in the treatment of early and late stage schizophrenia.

Until the late 1800s, drug development was a chance finding based on observations and repeated trials and errors. Today, drug development must go through many iterations and tests to ensure it is safe, potent, and effective. This process is a long and costly endeavor, with many pitfalls and hurdles. The aim of the present review article is to explore what is needed for a molecule to move from the researcher bench to the patients’ bedside, presented from an industry perspective through the development program of cariprazine. Cariprazine is a relatively novel antipsychotic medication, approved for the treatment of schizophrenia, bipolar mania, bipolar depression, and major depression as an add-on. It is a D3-preferring D3-D2 partial agonist with the highest binding to the D3 receptors compared to all other antipsychotics. Based on the example of cariprazine, there are several key factors that are needed for a molecule to move from the researcher bench to the patients’ bedside, such as targeting an unmet medical need, having a novel mechanism of action, and a smart implementation of development plans.

The aim of this chapter is to summarize the state-of-the-art knowledge of clinical staging in schizophrenia spectrum disorders. Clinical staging has been introduced to psychiatry in the past two decades. Its primary goal is to divide the course of the disorder into recognizable stages based on seriousness, development and symptom characteristics in order to better predict prognosis and to adopt the most appropriate treatment strategies. The first staging model was developed in 1982. Since then several distinct concepts of clinical staging in psychiatry have emerged. To date, there is no clinical consensus regarding which staging model is the gold standard, nonetheless when merging them together an integrated staging concept arises. The integrated staging model of schizophrenia spectrum disorders is composed of four stages. The chapter will introduce the different staging models in a historical order as well as present the integrated staging model detailing the characteristics, timeline and dominating symptoms of each stage. Appropriate treatment strategies for the distinct stages will also be outlined.

Background: Predominant negative symptoms (PNSs) in schizophrenia can affect the patients’ psychosocial functioning immensely and are less responsive to treatment than positive symptoms. Aims: The aim of the study was to observe negative symptoms and psychosocial functioning in PNS schizophrenia patients and to understand whether PNS can be improved and with what treatment strategies. Methods: This was a 1-year, prospective, multicentric cohort study conducted in Slovakia. Adult outpatients with diagnosis of schizophrenia according to ICD-10 and PNS evaluated using the criteria by the European Psychiatric Association’s (EPA) guidance were included. Change in negative symptoms, functionality, and treatment patterns were observed. Treatment effectiveness was evaluated using the modified Short Assessment of Negative Domain (m-SAND), the Self-evaluation of Negative Symptoms (SNS) scale, the Personal and Social Performance (PSP) scale, and the Clinical Global Impression – Severity (CGI-S) and the Clinical Global Impression – Improvement (CGI-I) scales. Least-squares (LS) means were calculated for the change from baseline to final visit for the outcomes. Results: The study included 188 patients. Functionality improved as, by the end of the study, fewer patients were unemployed (53%) and more worked occasionally (21%). PNS improved significantly according to both physicians and patients (LS mean change from baseline in m-SAND total score: -10.0 (p-value <0.0001)). Most patients received polytherapy throughout the study. Cariprazine was utilized most (20% monotherapy and 76% polytherapy). Only a few patients discontinued treatment due to adverse drug reactions. Conclusions: With the right treatment strategy, it is possible to achieve improvement in PNS and everyday functioning in schizophrenia outpatients.

Background: Measurement-based care (MBC) is widely recommended in psychiatry but remains underutilized in routine clinical settings. The Transdiagnostic Global Impression – Psychopathology (TGI-P) scale was developed to provide a brief yet comprehensive assessment of 10 core transdiagnostic symptom domains. To support more inclusive care and promote patient and caregiver engagement in treatment planning, two new versions of the TGI-P, that is, a patient-rated and a separate informant-rated, were developed, complementing the previously published clinician-rated version. Methods: The patient and informant versions mirror the original clinician-rated TGI-P, assessing the identical 10 domains using a seven-point Likert severity scale, with results displayed via a personalized symptom map. A user satisfaction/feasibility study was conducted with 50 participants (25 patients and 25 caregivers) from the UK and US. After completing the scale, participants provided feedback on its clarity, usability, emotional impact, and comparative utility. Results: Most participants completed the scale in less than 5 min. Instructions were considered clear, and the format was rated easy to follow. Response options were deemed appropriate by 86% of participants, and the visual output was widely appreciated. While one-third reported mild emotional triggering, overall burden was described as manageable. Approximately, three-quarters of participants rated the TGI-P as equal to or better than other tools they had used. Conclusions: TGI-P patient and informant versions were developed and, informed by the feasibility study, refined to offer brief, user-friendly tools that support multi-informant assessment as input to MBC. Both versions of the TGI-P, with their graphical output, may support shared understanding and collaborative decision making among clinicians, patients, and caregivers. A validation study of the TGI-P is underway.