The animated assessment of theory of mind for people with schizophrenia (AToMS): development and psychometric evaluation

Theory of mind (ToM) deficits in people with schizophrenia have been reported and associated with impaired social interactions. Thus, ToM deficits may negatively impact social functioning and warrant consideration in treatment development. However, extant ToM measures may place excessive cognitive demands on people with schizophrenia. Therefore, the study aimed to develop a comprehensible Assessment of ToM for people with Schizophrenia (AToMS) and evaluate its psychometric properties. The AToMs was developed in 5 stages, including item formation, expert review, content validity evaluation, animation production, and cognitive interviews of 25 people with schizophrenia. The psychometric properties of the 16-item AToMS (including reliability and validity) were then tested on 59 people with schizophrenia. The newly developed animated AToMS assesses 8 ToM concepts in the cognitive and affective dimensions while placing minimal neurocognitive demands on people with schizophrenia. The AToMS presented satisfactory psychometric properties, with adequate content validity (content validity index = 0.91); mostly moderate item difficulty (item difficulty index = 0.339–0.966); good discrimination (coefficients = 0.379–0.786), internal consistency (Cronbach’s α = 0.850), and reliability (intraclass correlation coefficient = 0.901 for test–retest, 0.997 for inter-rater); and satisfactory convergent and divergent validity. The AToMS is reliable and valid for evaluating ToM characteristics in people with schizophrenia. Future studies are warranted to examine the AToMS in other populations (e.g., people with affective disorders) to cross-validate and extend its utility and psychometric evidence.

     

The Reliability and Validity of the MATRICS Functional Assessment Battery

Objectives: The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) initiative was designed to encourage the development of cognitive enhancing agents for schizophrenia. For a medication to receive this indication, regulatory agencies require evidence of improvement in both cognition and functional outcome. Functional capacity measures typically used in clinical trials as intermediate measures of functional outcome must be adapted to fit different cultural contexts for use internationally. We examined the psychometric properties of the MATRICS Functional Assessment Battery (MFAB), comprised of 2 subtests from the UCSD Performance-based Skills Assessment (UPSA) and one from the Test of Adaptive Behavior in Schizophrenia (TABS) that were rated by experts in a previous study to be the most appropriate functional capacity assessments across different cultural contexts. Method: Four sites in India administered the MFAB, a brief version of the UPSA, the MATRICS Cognitive Consensus Battery, measures of symptomatology, and a measure of global functional outcome to 141 individuals with schizophrenia at a baseline assessment and at 4 weeks later. Results: Test-retest reliability based on the intraclass correlation coefficient was significantly better for the UCSD Performance-Based Skills Assessment-Brief (UPSA-B). Pearson correlation coefficients over time were not significantly different for the 2 measures. Only the MFAB was significantly correlated with functional outcome as measured by the Specific Levels of Functioning Scale. Conclusions: The psychometric properties of the MFAB and UPSA-B were similar. The MATRICS scientific board chose to translate the MFAB into multiple languages for potential use in studies of novel medications seeking an indication for improving cognition in schizophrenia.Key words: schizophrenia, co-primary measures, intermediate measures, international clinical trials, functional capacity measures, cognitive impairments     

Designing and validation of a yoga-based intervention for schizophrenia

Abstract

Context: Schizophrenia is a chronic mental illness which causes significant distress and dysfunction. Yoga has been found to be effective as an add-on therapy in schizophrenia. Modules of yoga used in previous studies were based on individual researcher’s experience.

Aim: This study aimed to develop and validate a specific generic yoga-based intervention module for patients with schizophrenia. The study was conducted at NIMHANS Integrated Centre for Yoga (NICY).

Materials and methods: A yoga module was designed based on traditional and contemporary yoga literature as well as published studies. The yoga module along with three case vignettes of adult patients with schizophrenia was sent to 10 yoga experts for their validation.

Results: Experts (n?=?10) gave their opinion on the usefulness of a yoga module for patients with schizophrenia with some modifications. In total, 87% (13 of 15 items) of the items in the initial module were retained, with modification in the remainder as suggested by the experts.

Conclusion: A specific yoga-based module for schizophrenia was designed and validated by experts. Further studies are needed to confirm efficacy and clinical utility of the module. Additional clinical validation is suggested.     

Association between brain structure and psychometric schizotypy in healthy individuals

Abstract

Objectives. Schizophrenia is associated with replicable grey matter volume reductions in fronto-temporo-limbic and subcortical regions. Psychometric schizotypy refers to a set of behavioural traits and cognitions thought to represent the subclinical manifestation of schizophrenia in the general population. While there is evidence of a continuum between schizophrenia and schizotypy at phenotypic, genetic and cognitive levels, no previous study has observed grey matter volume reductions associated with increased psychometric schizotypy levels in healthy individuals. Such evidence would provide further support for a relationship between non-clinical schizophrenia-like traits in the general population and the full-blown clinical condition of schizophrenia. Methods. We used magnetic resonance imaging to investigate the relationship between psychometric schizotypy and brain structure in 55 clinically unaffected and unmedicated volunteers. We performed a voxel-based morphometry analysis of grey matter volume data obtained at 1.5 Tesla. Results. Covarying for age and gender, higher scores of self-report positive schizotypy were significantly associated with reduced grey matter volume in medial prefrontal, orbitofrontal, and temporal cortical regions. Conclusions. These findings show that psychometric schizotypy in healthy individuals is associated with volume reductions in cortical areas known to be altered in schizophrenia, thereby providing neurobiological evidence of a continuum between schizotypy and schizophrenia.     

The incidence of non-affective psychotic disorders in low and middle-income countries: a systematic review and meta-analysis

Purpose

Global understanding of the epidemiological landscape of non-affective psychotic disorders (NAPD) is predominantly based on studies from high-income countries. We sought to systematically review and meta-analyse all incidence studies conducted in low and middle-income countries (LMICs).

Methods

We systematically searched four databases using terms for NAPD, incidence and LMICs. Citations were eligible for inclusion if: published between 1 January 1960 and 31 May 2022; wholly or partially conducted in an LMIC, and; containing data on NAPD incidence in the general adult population. Two independent raters assessed study quality according to previously published criteria. We conducted a narrative synthesis and random-effects meta-analyses where sufficient studies were available (N ≥ 5).

Results

We retrieved 11 421 records, of which 23 citations met inclusion criteria from 18 unique studies across 19 settings in 10 LMICs. Median study quality was 4 out of 7 (interquartile range: 3–6). The crude incidence of NAPD varied around 4.2 times, from 10.0 per 100,000 person-years (95% confidence interval [CI] 8.7–11.4) in Brazil to 42.0 (95%CI 32.2–54.8) in India, with marked heterogeneity in methodologies and rates. Our 60-year review highlights the dearth of robust evidence on the incidence of psychotic disorders in LMICs.

Conclusion

Without reliable, contemporary estimates of this fundamental cornerstone of population health, it is impossible to understand the true burden, distribution or causes of psychotic disorders in over 87% of the world’s population. A new, more equitable global mental health evidence base for NAPD is now urgently required.

     

Korean Facial Emotion Recognition Tasks for Schizophrenia Research

ObjectiveDespite the fact that facial emotion recognition (FER) tasks using Western faces should be applied with caution to non-Western participants or patients, there are few psychometrically sound and validated FER tasks featuring Easterners'' facial expressions for emotions. Thus, we aimed to develop and establish the psychometric properties of the Korean Facial Emotion Identification Task (K-FEIT) and the Korean Facial Emotion Discrimination Task (K-FEDT) for individuals with schizophrenia.MethodsThe K-FEIT and K-FEDT were administered to 42 Korean individuals with schizophrenia to evaluate their psychometric properties. To test the convergent and divergent validities, the Social Behavior Sequencing Task (SBST) and hinting task were administered as social-cognitive measures, and the Trail Making Test (TMT)-A and -B were administered as neurocognitive measures.ResultsAverage accuracy on the K-FEIT and K-FEDT were 63% and 74%, respectively, and internal consistencies of the K-FEIT and K-FEDT were 0.82 and 0.95, respectively. The K-FEIT and K-FEDT were significantly correlated with SBST and Hinting Task, but not with TMT-A and B.ConclusionFollowing replication studies in a larger sample, the K-FEIT and K-FEDT are expected to facilitate future studies targeting facial emotion recognition in schizophrenia in Korea. Limitations and directions for future research are discussed.     

Everyday memory measures in multiple sclerosis: a systematic review

ABSTRACT

Everyday memory is one of the most affected cognitive functions in multiple sclerosis (MS). Assessing everyday memory problems is crucial for monitoring the impact of memory deficits on individuals’ day-to-day lives and evaluating the effectiveness of interventions that aim to improve cognitive functions. The aim of this systematic review was to identify the research literature on everyday memory measures used with people with MS, describe the types of measures used, and summarise their psychometric properties. Empirical studies of cognitive function in MS using standardised everyday memory measures were included. Online databases (MEDLINE, PsycINFO, PsycARTICLES, Embase) and Google Scholar were searched. Forty-four studies met the inclusion criteria. A total of 12 measures were identified, with varied uses and administration methods. The majority of papers did not report any psychometric properties for MS populations. The few papers that did, reported that the measures have good reliability and appear to have good face, concurrent, and ecological validity, but these need to be evaluated further. This review presents researchers and clinicians with an overview of the various everyday memory measures used in studies with people with MS, to help them choose the appropriate measure for their evaluations.     

Childhood trauma and cardiometabolic risk in severe mental disorders: The mediating role of cognitive control

BackgroundCardiometabolic risk is increased in severe mental disorders (SMDs), and there appears to be a relationship between childhood trauma and cardiometabolic risk, possibly related to adverse health behavior. The current study examined the association between childhood trauma and serum lipids and adiposity in SMDs and the potential mediating role of cognitive and personality characteristics.MethodsParticipants with schizophrenia and bipolar spectrum disorders (N = 819) were included, cardiometabolic risk factors (serum lipids, body mass index, and waist circumference) were measured, and history of childhood trauma was assessed by the Childhood Trauma Questionnaire. Cognitive and personality characteristics were available in subsamples, with assessments of cognitive control, impulsiveness, self-esteem, and affective lability. Linear regressions and mediation analyses with Hayes’ PROCESS were performed, adjusting for age, sex, antipsychotic agent propensity of metabolic side-effect, and diagnostic group.ResultsExperience of three or more subtypes of childhood trauma was positively associated with waist circumference in patients with SMDs (p = 0.014). There were no other significant associations between trauma variables and lipid or adiposity measures in the total sample. Cognitive control was a significant mediator between experience of one or two subtypes of childhood trauma and waist circumference.ConclusionsThe results indicate childhood trauma as a predisposing factor for increased waist circumference in individuals with SMDs. Poorer cognitive control, suggestive of adverse health behavior, might be a mediating factor of the association, and the findings indicate the potential importance of increased focus on these factors in prevention and treatment regimens targeting cardiometabolic health.     

Association between schizophrenia symptoms and neurocognition on mobility in older adults with schizophrenia

Objectives: Older persons with schizophrenia develop problems associated with aging, such as poor mobility, at more rapid rates than people without serious mental illness. Decrements in mobility contribute to poor health outcomes. Impaired neurocognitive function and psychiatric symptoms are central aspects of schizophrenia. The purpose of this study was to determine the association between neurocognitive impairment and schizophrenia symptoms to mobility in older adults with schizophrenia.

Methods: A cross-sectional study with 46 older adults with schizophrenia. Participants were assessed on neurocognitive function (MATRICS Consensus Cognitive Battery), psychiatric symptoms (Positive and Negative Syndrome Scale or PANSS), and mobility (Timed Get Up and Go or TGUG test). Pearson's bivariate correlations (two-tailed) and a simultaneous regression model were used.

Results: Lower severity of negative symptoms and faster speed of processing tests were associated with faster TGUG time in bivariate correlations and multivariate regression analyses (p < .05).

Conclusion: Our data suggest that lower negative symptoms and faster speed of processing positively impact mobility in older patients with schizophrenia. Mobility interventions for this population need to target neurocognitive impairment and schizophrenia symptoms for optimal results.     

Ethnic inequalities in clozapine use among people with treatment-resistant schizophrenia: a retrospective cohort study using data from electronic clinical records

Purpose

Clozapine is the most effective intervention for treatment-resistant schizophrenia (TRS). Several studies report ethnic disparities in clozapine treatment. However, few studies restrict analyses to TRS cohorts alone or address confounding by benign ethnic neutropenia. This study investigates ethnic equity in access to clozapine treatment for people with treatment-resistant schizophrenia spectrum disorder.

Methods

A retrospective cohort study, using information from 11 years of clinical records (2007–2017) from the South London and Maudsley NHS Trust. We identified a cohort of service-users with TRS using a validated algorithm. We investigated associations between ethnicity and clozapine treatment, adjusting for sociodemographic factors, psychiatric multi-morbidity, substance misuse, neutropenia, and service-use.

Results

Among 2239 cases of TRS, Black service-users were less likely to be receive clozapine compared with White British service-users after adjusting for confounders (Black African aOR = 0.49, 95% CI [0.33, 0.74], p = 0.001; Black Caribbean aOR = 0.64, 95% CI [0.43, 0.93], p = 0.019; Black British aOR = 0.61, 95% CI [0.41, 0.91], p = 0.016). It was additionally observed that neutropenia was not related to treatment with clozapine. Also, a detention under the Mental Health Act was negatively associated clozapine receipt, suggesting people with TRS who were detained are less likely to be treated with clozapine.

Conclusion

Black service-users with TRS were less likely to receive clozapine than White British service-users. Considering the protective effect of treatment with clozapine, these inequities may place Black service-users at higher risk for hospital admissions and mortality.

     

Measuring self-harm in adults: A systematic review

PurposeTo identify from the literature, and to critically evaluate, all validated instruments currently available to measure self-harming behaviour in adults.Materials and methodsMedline, Embase, PsycInfo, Health and Psychosocial Instruments and Google scholar were searched, grey literature was sought and the reference lists of relevant articles were checked to identify instruments.ResultsA total of seven validated instruments which met our inclusion criteria were identified and data were extracted regarding each instrument's format, administration method, psychometric properties and number of items and domains included. Considerable variation was observed in the overall quality of these instruments. Fourteen other instruments were identified which did not describe their psychometric properties or had not been published and were subsequently excluded from our review.DiscussionAlthough many instruments were identified in our search, only a small number had been validated with published psychometric properties. Of the identified instruments, the Suicide Attempt Self-Injury Interview (SASII) appears to be the most robust and comprehensive instrument currently available. Despite the absence of psychometric data, numerous other instruments have been used in published studies, including clinical trials.ConclusionOur results highlight the pressing need for a standardized, empirically validated and versatile measure of intentional self-harming behaviour for use in both clinical and research settings. The optimum characteristics of such an instrument are discussed.     

Validation of the Danish version of the brief negative symptom scale

Abstract

Objective: The Brief Negative Symptom Scale (BNSS) is an instrument for evaluating negative symptoms (NS) in schizophrenia based on the 2005 consensus statement by the National Institute of Mental Health. This study examines the validity and reliability of the Danish version of BNSS.

Materials and methods: Acutely and chronically affected patients with schizophrenia or schizoaffective disorder were assessed with BNSS along with other psychopathological scales and clinical measures. Convergent and discriminant validity of BNSS was evaluated by its relationships with these assessments. Inter-rater agreement was estimated by the intraclass correlation coefficient (ICC).

Results: Forty-nine subjects were included; the mean age was 33.1 (±10.8) years and 32 (65%) were males. BNSS correlated strongly with traditional assessment tools for NS and poorly with measures of depressive and extrapyramidal symptoms, except for Parkinsonism. Moreover, BNSS correlated well with the assessment of positive symptoms. The ICC of BNSS was 0.95 (n?=?19, 95% CI: 0.88–0.98).

Conclusions: Overall, BNSS holds appropriate psychometric properties in terms of reliability and validity. However, discriminant validity was compromised by correlations with positive symptoms and Parkinsonism. The former originates presumably from NS secondary to positive symptoms since the sample included acutely psychotic patients, and the latter from overlapping rating criteria regarding facial expressivity impairment.     

Positive and negative impacts of schizophrenia on family caregivers: a systematic review and qualitative meta-summary

Purpose

Schizophrenia places a heavy burden on the individual with the disorder, as well as on his or her family; this burden continues over the long course of the disease. This study aimed to provide an overview of the positive and negative impacts of schizophrenia on family caregivers.

Methods

From April to June 2017, two investigators conducted a systematic review and meta-summary of studies obtained from five electronic databases and the footnotes and citations of eligible studies. Qualitative studies that explored the experiences of family caregivers of individuals with schizophrenia were included. Study findings published between 1993 and 2017 were extracted and synthesised using narrative and summative approaches.

Results

After the removal of duplicates, independent reviewers screened 864 records. Subsequently, 46 full-text articles were assessed for eligibility and 23 papers were included in the synthesis. Negative impacts identified were traumatic experiences, loss of expectation of life and health, lack of personal and social resources, uncertainty and unpredictability, family disruption, conflict in interpersonal relationships, difficulty in understanding, and stigma and heredity. Meanwhile, the positive impacts identified were family solidarity, admiration, affirmation, affection, compassion, learning knowledge and skills, self-confidence, personal growth, and appreciation.

Conclusions

Analysis of the studies suggested that family members of individuals with schizophrenia face a series of traumatic situations during the course of the illness. Their subsequent experiences can be conceptualised as a continuous circle of caregiving, in which the positive impacts can be centrally positioned within the negative impacts.

     

Plasma total antioxidant status and cognitive impairments in schizophrenia

Oxidative stress-induced damage to neurons may contribute to cognitive deficits during aging and in neurodegenerative disorders. Schizophrenia has a range of cognitive deficits that may evolve from oxidative stress, and this study examines this association of oxidative stress with cognitive deficits in schizophrenia. We recruited 296 chronic schizophrenia patients and 181 healthy control subjects and examined the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and plasma total antioxidant status (TAS) in both groups. Schizophrenia symptoms were assessed using the positive and negative syndrome scale (PANSS). Our results showed that TAS levels were significantly lower in patients than controls (179.6 ± 81.0 U/ml vs. 194.8 ± 46.0 U/ml, p<0.05). Cognitive scores on the RBANS and nearly all of its five subscales (all p<0.001) except for the Visuospatial/Constructional index (p>0.05) were significantly lower in schizophrenia patients than normal controls. For the patients, TAS was inversely associated with some domains of cognitive deficits in schizophrenia, such as Attention and Immediate Memory. Our findings suggest that oxidative stress may be involved in the pathophysiology of schizophrenia, and its associated cognitive impairment.     

Impaired musical ability in people with schizophrenia

BackgroundAssessment of the musical ability of people with schizophrenia has attracted little interest despite the diverse and substantive findings of impairments in sound perception and processing and the therapeutic effect of music in people with the illness. The present study investigated the musical ability of people with schizophrenia and the association with psychiatric symptoms and cognition.MethodsWe recruited patients with chronic schizophrenia and healthy controls for participation in our study. To measure musical ability and cognitive function, we used the Montreal Battery of Evaluation of Amusia (MBEA) and the Brief Assessment of Cognition in Schizophrenia (BACS). We carried out a mediation analysis to investigate a possible pathway to a deficit in musical ability.ResultsWe enrolled 50 patients and 58 controls in the study. The MBEA global score in patients with schizophrenia was significantly lower than that in controls (p < 0.001), and was strongly associated with both the composite cognitive function score (r = 0.645, p < 0.001) and the negative symptom score (r = −0.504, p < 0.001). Further analyses revealed direct and indirect effects of negative symptoms on musical ability. The indirect effects were mediated through cognitive impairment.LimitationsThe relatively small sample size did not permit full evaluation of the possible effects of age, sex, education, medication and cultural influences on the results.ConclusionExamining the associations between musical deficits, negative symptoms and cognitive imapirment in patients with schizophrenia may identify shared biological mechanisms.     

The psychometric properties of the control,autonomy, self-realisation and pleasure scale (CASP-19) for older adults with dementia

Introduction: Asset based approaches to dementia research and measurement emphasise the need to also assess the strengths and capabilities that people with dementia retain, rather than assessing only losses or deficits. The CASP-19 proposes wellbeing as the satisfaction of four ‘needs’ (control, autonomy, self-realisation and pleasure). The CASP-19 may reflect the asses-based approach and has been validated in over 20 countries. The aim of this study was to evaluate the CASP-19's psychometric properties in older adults with dementia.

Methods: An observational study was conducted at five NHS trusts across England. Participants were asked to either complete the CASP-19 by interview or self-report, alongside four other measures to assess psychometric properties.

Results: Internal consistency overall was good (α = .856) but the autonomy subscale fell below the acceptable. The CASP-19 was significantly correlated in the expected direction with measures of quality of life (r = .707), depression (r = ?.707) and additional measures. It also remained moderately stable over a one-week period but factor analyses indicated a 12-item measure may be more robust.

Conclusions: Despite some variations, the CASP-19 appears to have adequate psychometric properties for older adults with dementia and can be used in future research and practice.     

The association between early-onset schizophrenia with employment,income, education,and cohabitation status: nationwide study with 35 years of follow-up

Purpose

Individuals with schizophrenia have been reported to have low employment rates. We examined the associations of schizophrenia with employment, income, and status of cohabitation from a work life course perspective.

Methods

Nationwide cohort study including all individuals (n = 2,390,127) born in Denmark between 1955 and 1991, who were alive at their 25th birthday. Diagnosis of schizophrenia (yes/no) between ages 15 and 25 was used as an exposure. Employment status, annual wage or self-employment earnings, level of education, and cohabitant status from the age of 25–61 (years 1980–2016) were used as outcomes.

Results

Schizophrenia diagnosis between ages 15 and 25 (n = 9448) was associated with higher odds of not being employed (at the age of 30: OR 39.4, 95% CI 36.5–42.6), having no secondary or higher education (7.4, 7.0–7.8), and living alone (7.6, 7.2–8.1). These odds ratios were two-to-three times lower and decreasing over time for those individuals who did not receive treatment in a psychiatric inpatient or outpatient clinic for schizophrenia after the age of 25. Between ages 25–61, individuals with schizophrenia have cumulative earning of $224,000, which is 14% of the amount that the individuals who have not been diagnosed with schizophrenia earn.

Conclusions

Individuals with schizophrenia are at high risk of being outside the labour market and living alone throughout their entire life, resulting in an enormous societal loss in earnings. Individuals with less chronic course of schizophrenia had a gradual but substantial improvement throughout their work life.

     

The FDA-NIMH-MATRICS Guidelines for Clinical Trial Design of Cognitive-Enhancing Drugs: What Do We Know 5 Years Later?

The Food and Drug Administration (FDA)-National Institute of Mental Health (NIMH)-Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) clinical trial guidelines for cognitive-enhancing drugs in schizophrenia and the MATRICS Consensus Cognitive Battery (MCCB) were designed to facilitate novel compound development in the treatment of cognitive impairments. Several studies have recently utilized the FDA-NIMH-MATRICS guidelines and MCCB and allow an evaluation of the feasibility of guideline implementation and MCCB performance. In light of the study results, we would recommend the following inclusion criteria revisions—(1) clinical status and symptom inclusion criteria: maximum allowed score for hallucinations and delusions should be increased from moderate to moderately severe and the negative symptom criterion should be dropped in phase 2 studies; (2) antipsychotic medication inclusion criteria: first-generation antipsychotics should be allowed, but only in the context of no concomitant anticholinergic agents and minimal extrapyramidal symptoms, and antipsychotic polypharmacy should be allowed in the absence of pertinent pharmacokinetic or pharmacodynamic considerations; and (3) people who use illicit substances should not be allowed in phase 1B or 2A proof-of-concept studies but may be included in phase 2B and 3 studies in which proof of effectiveness and generalizability of results become more important goals. These revisions are recommended to enhance recruitment while maintaining sufficient methodological rigor to ensure the validity of study results. The MCCB has been shown to have excellent psychometric characteristics, including reliability for multisite clinical trials, clinical relevance for real-world functioning, and possible sensitivity to behavioral treatment, and should continue to serve as the standard outcome measure for cognitive enhancement studies in schizophrenia.     

An open-treatment six-week study of the clinical effectiveness of Paliperidone Palmitate in schizophrenia: data from acute units in Spain (SHADOW study)

Objectives: To evaluate clinical evolution of patients with schizophrenia admitted in acute units because of a relapse and treated with once-monthly Paliperidone Palmitate (PP1M).

Methods: This multicentre, open-label, prospective observational study followed patients with schizophrenia treated with PP1M in acute psychiatric units for up to 6 weeks.

Results: Out of the 280 enrolled patients, 61 received PP1M as antipsychotic monotherapy, and 219 in combination with other antipsychotics. The average Clinical Global Impression–Schizophrenia (CGI-SCH) score decreased from 4.7 at baseline to 3.3 at final visit (p?p?Conclusions: PP1M was effective and well tolerated in treatment of acute episodes of schizophrenia both in monotherapy and in combination with other antipsychotics in clinical setting. Early start of PP1M therapy in acute schizophrenia episodes might help to shorten hospital stay.