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A double-blind, randomized, active-controlled, parallel-group, noninferiority trial (NCT03345342) demonstrated that paliperidone palmitate once-every-6-months (PP6M) was noninferior to paliperidone palmitate once-every-3-months (PP3M) in preventing relapse in clinically stable adults with schizophrenia. This post hoc analysis assessed efficacy and safety following transition to PP6M from paliperidone once-monthly (PP1M) versus PP3M.
Methods
Adults with schizophrenia who were clinically stable on moderate/high doses of PP1M or PP3M were randomly assigned 1:2 to dorsogluteal PP3M or PP6M treatment for 12 months. The primary efficacy measure was time to relapse during the 12-month DB phase. Secondary endpoints included change from DB baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total and subscale scores, Clinical Global Impression-Severity (CGI-S) scale score, and Personal and Social Performance (PSP) scale score. Safety was assessed by treatment-emergent adverse events (TEAEs), vital signs, and clinical laboratory tests.
Results
Of 702 patients in the study, 231 transitioned from PP1M to PP6M and 247 transitioned from PP3M to PP6M. Low relapse rates for PP6M were observed regardless of transition pathway (PP1M/PP6M: 7.8%; PP3M/PP6M: 7.3%). Changes from DB baseline to endpoint in PANSS total, PSP, and CGI-S scores were similar between transition groups. In the DB phase, ≥1 TEAE was observed in 61.0% and 63.2% of patients in the PP1M/PP6M and PP3M/PP6M, groups, respectively.
Conclusion
Adults with schizophrenia who transitioned to PP6M from either PP1M or PP3M experienced similarly low relapse rates. Additionally, symptom and functionality scores supported the primary analysis and, along with TEAE incidences, were comparable between transition groups.
Modern psychometric methods make it possible to eliminate nonperforming items and reduce measurement error. Application of these methods to existing outcome measures can reduce variability in scores, and may increase treatment effect sizes in depression treatment trials.
Aims
We aim to determine whether using confirmatory factor analysis techniques can provide better estimates of the true effects of treatments, by conducting secondary analyses of individual patient data from randomised trials of antidepressant therapies.
Method
We will access individual patient data from antidepressant treatment trials through Clinicalstudydatarequest.com and Vivli.org, specifically targeting studies that used the Hamilton Rating Scale for Depression (HRSD) as the outcome measure. Exploratory and confirmatory factor analytic approaches will be used to determine pre-treatment (baseline) and post-treatment models of depression, in terms of the number of factors and weighted scores of each item. Differences in the derived factor scores between baseline and outcome measurements will yield an effect size for factor-informed depression change. The difference between the factor-informed effect size and each original trial effect size, calculated with total HRSD-17 scores, will be determined, and the differences modelled with meta-analytic approaches. Risk differences for proportions of patients who achieved remission will also be evaluated. Furthermore, measurement invariance methods will be used to assess potential gender differences.
Conclusions
Our approach will determine whether adopting advanced psychometric analyses can improve precision and better estimate effect sizes in antidepressant treatment trials. The proposed methods could have implications for future trials and other types of studies that use patient-reported outcome measures.
Attention-Deficit/Hyperactivity Disorder (ADHD) was classically considered a childhood-onset neurodevelopmental condition. Over the past 40 years, it became evident that it can persist during adulthood.
Objectives
The purpose of the authors is to describe the characteristics of ADHD in adults and the specific comorbidities, proposing an approach to these patients.
Methods
A brief non-systematized review is presented, using the literature available on PubMed and Google Scholar.
Results
Only 40-50% of children and adolescents with ADHD will have symptoms that persist into adulthood (estimated adult prevalence of 2.8% across 20 countries; 25% in prisons). A more subtle presentation in adults and the difficulty to access past medical history, lead to diagnosis and treatment rates of lower than 20% (versus 50% in children). Well-characterized core symptoms in children evolve into a predominance of inattention symptoms. They became adults with marked disorganization, difficulties in completing tasks and managing time. Emotional dysregulation is a very prevalent symptom in this population. The comorbidities rate increase over time (reaching 75% of patients).
Conclusions
Adults (or even older subjects) with cognitive and/or behavioural complaints should be submitted to systematic screening for ADHD. Non-treated ADHD symptoms in adulthood are associated with severe impairment, therefore adjustments in the health care system to support the transition from child to adult services are needed.
Adults with neurodevelopmental disorders frequently present to, but fit uneasily into, adult mental health services. We offer definitions of important terms related to neurodevelopmental disorders through unifying research data, medical and other viewpoints. This may improve understanding, clinical practice and development of neurodevelopmental disorder pathways within adult mental health services.
This chapter focuses on the clinical phenomenology and descriptive classification of unipolar disorders of childhood. The advent of reliable and valid measures of present mental state in children and adolescents has greatly advanced our understanding of major (unipolar) depression. Research confirms that the clinical picture of affective disorders in children and adolescents resembles the presentation of that in adults. Comorbidity is the concurrent presence of two or more disorders greater than expectation by chance alone. The first way of defining depressive subsyndromes in childhood is the clinical approach where clinical pictures are drawn, utilizing an inductive method combined with clinical judgement. The second is a statistical approach using multivariate procedures such as exploratory factor analysis. What has not yet emerged is a clear idea of the proportions of prior disorders which shift into major depression, and the proportion of major depressive disorder (MDD) that remain 'uncontaminated' by comorbidity.
The social network of any individual may be held to comprise those with whom the person has regular face-to-face interaction and some degree of commitment. Social support may be seen simply as the provision of help and advice by other people. Henderson has listed three separate hypotheses about the effects of social support. First, that social support has a direct and independent effect in its own right on mental and/or physical health, whether or not adversity is also present; second, that it provides a buffer or cushioning effect against stress; third, that in persons who have already developed affective or neurotic symptoms, it has a therapeutic effect shortening the episode and reducing symptoms. Clinical work with patients in both child and adult psychiatry is a constant reminder of how the interactions between parents and children influence, for better and for worse, psychosocial development in the children.
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