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Minimal long-term benefit: Risk data are available regarding antipsychotic treatments for schizophrenia in pediatric populations. This study evaluated the long-term safety, tolerability, and effectiveness of lurasidone in adolescents with schizophrenia.
Patients aged from 13 to 17 who completed 6 weeks of double-blind (DB), placebo-controlled treatment with lurasidone were enrolled in a 2-year, open-label (OL), flexible dose (20-80 mg/day) lurasidone treatment study. Safety was assessed via spontaneous reporting, rating scales, body weight measurement, metabolic, and prolactin testing. Effectiveness measures included the Positive and Negative Syndrome Scale (PANSS) total score.
About 271 patients completed 6 weeks of DB treatment and entered the 2-year OL extension study. Altogether, 42.4% discontinued prematurely, 10.7% due to adverse events. During OL treatment, the most common adverse events were headache (24.0%); anxiety (12.9%), schizophrenia, and nausea (12.5%); sedation/somnolence (12.2%); and nasopharyngitis (8.9%). Minimal changes were observed on metabolic parameters and prolactin. Mean change from DB baseline in weight at week 52 and week 104 was +3.3 kg and + 4.9 kg, respectively, compared to an expected weight gain of +3.4 kg and + 5.7 kg, respectively, based on the sex- and age-matched US Center for Disease Control normative data. Continued improvement was observed in PANSS total score, with mean change from OL baseline of −15.6 at week 52 and −18.4 at week 104.
In adolescents with schizophrenia, long-term lurasidone treatment was associated with minimal effects on body weight, lipids, glycemic indices, and prolactin. Continued improvement in symptoms of schizophrenia was observed over 2 years of lurasidone treatment.
This chapter describes how the transtheoretical model of behavior change (TTM) provides a framework to guide the development of tailored behavior change interventions. The TTM includes four critical concepts: stages of change to delineate critical motivational and behavior change tasks; processes of change to identify a multidimensional set of mechanisms individuals use to accomplish stage tasks and make change happen; context of change to identify contextual resources and problems that promote or hinder personal change; and markers of change that are used to track important decisional and self-efficacy dimensions related to movement through the process of change. The TTM has been used to develop interventions for pre-action and action-oriented stage tasks and offers a unique perspective for understanding how behavior changes. TTM constructs have been used and evaluated in diverse clinical and cultural settings with both mental and physical health conditions. There is substantial support for the constructs and for tailoring interventions using these constructs across multiple studies. This chapter offers concrete strategies from diverse intervention approaches that can be used to address the varied motivation and behavior change tasks represented by the stages of change. Finally, implications for prevention, treatment, and training are discussed.
Knowing how energy intake is partitioned between maintenance, growth and egg production (EP) of birds makes it possible to structure models and recommend energy intakes based on differences in the BW, weight gain (WG) and EP on commercial quail farms. This research was a dose-response study to re-evaluate the energy partition for Japanese quails in the EP phase, based on the dilution technique to modify the retained energy (RE) of the birds. A total of 300 VICAMI® Japanese quail, housed in climatic chambers, were used from 16 weeks of age, with averages for BW of 185 g and EP of 78%, for 10 weeks. To modify the RE in the bird’s body, a qualitative dilution of dietary energy was used. Ten treatments (metabolisable energy levels) were distributed in completely randomised units, with six replicates of five quails per experimental unit. Metabolisable energy intake (MEI), egg mass (EM) and RE were expressed in kJ/kg0.67. The utilisation efficiency (kt) was estimated from the relationship between RE and MEI. The metabolisable energy for maintenance was given by RE = 0. The net energy requirement for WG was obtained from the relationship between RE in the BW as a function of the BW. The utilisation efficiency for EP (ko) was obtained from the relationship between EM and RE corrected MEI for maintenance and WG. Based on these efficiencies, the requirements for WG and EM were calculated. The energy intake by Japanese quails was partitioned according to the model: MEI = 569.8 × BW0.67 + 22 × WG + 13 × EM. The current study provides procedures and methods designed for quails as well as a simple and flexible model that can be quickly adopted by technicians and poultry companies.
Warfarin is highly effective in killing rats, and in the hands of the uneducated, is just as effective in killing humans. The author provides tips for getting it right every time, including how to initiate treatment, how to reverse its effects, and drug and food interactions to watch out for.
Marriage was often a way to contain the poverty of women and children and sometimes men. Men were expected to be the family breadwinners, earning enough to feed, clothe and house their wife and children. In reality, poorer women were always obliged to assist in supplementing or securing the family income, as were children. For many women, the desertion of a husband brought them and their children to destitution and they ended up in the workhouse. Desertion could occur at any point in a marriage, sometimes after a couple of days or even years later. The large number of newspaper notices placed by husbands cautioning the public that they would not pay any bills accumulated by their runaway wives testify to the way in which men and women took matters into their own hands to abandon a difficult marriage, without consulting a lawyer or, in many cases, their spouse. Sometimes spouses agreed to a desertion as a way of separating. The evolution of the law throughout the period saw the removal of legal constraints placed upon women granting them, for instance, greater property rights and economic autonomy. By the end of the nineteenth century, the law provided more substantial support to women who were deserted, or separated, particularly in the area of securing maintenance payments.
The challenge of user requirements for maintenance scheduling design in large asset-intensive industries suffers from lack of academic and empirical studies. Therefore, using a representative case study, this paper aims to: (1) identify the current practices and complex scheduling requirements; (2) propose a design support tool to optimize the maintenance scheduling process; and (3) report the gained benefits. The results reveal that the proposed tool can decrease the resource requirements, increase the capacity utilization, and reduce the cost while addressing the complex user requirements.
Each individual in the population has a distinct maximum growth potential, and the growth curve may vary depending on the response to nutrient intake, growth phase and variability among animals. The present study aimed to (1) model weight gain (WG) response to methionine+cystine (Met+Cys) supply using different mathematical functions, (2) identify functions that better fit the growth responses of pullets, (3) determine the Met+Cys requirements that maximize WG based on breeding standards and (4) partition the Met+Cys requirements for WG and maintenance. Three trials were performed using 1448 laying-type pullets. We adopted a completely randomized design with eight treatments and six replicates. The first trial (2 to 6 weeks, P1) used 15 pullets per experimental unit. The second and third trials (8 to 12 weeks, P2; 14 to 18 weeks, P3) were used eight pullets per replicate. The Met+Cys levels were obtained using a dilution technique. The mathematical functions used to describe WG responses to Met+Cys intake were broken line, broken line with curvilinear ascendancy, Michaelis–Menten, saturation kinetics and three logistic and three exponential models. Models were selected using the Bayesian information criterion and evaluated by residual analysis. It was possible to model the responses using the studied functions. The best functions were obtained by logistic and sigmoidal models in P1 and P2, and with the broken line by the curvilinear ascendancy model in P3. The Met+Cys intake that determined the maximum potential for WG (WGmax) in P1, P2 and P3 were 313, 381 and 318 mg/day, respectively. The Met+Cys requirements for WG were 20, 22 and 27 mg/g, and for maintenance were 214, 53 and 30 mg/kgBW0.75 for P1, P2 and P3, respectively.
L’efficacité de l’électroconvulsivothérapie (ECT) dans la prise en charge des troubles de l’humeur, notamment dans les situations d’urgence, n’est plus à prouver. En effet les études comparatives et essais cliniques ont montré que le traitement par ECT était efficace dans tous les types d’épisodes dépressifs majeurs avec notamment un taux de réponse de 80 à 90 % lorsque l’ECT était pratiqué dans le cadre d’un premier épisode dépressif (APA, 2001). Cependant, une méta-analyse récente a mis en évidence un taux de rechute des épisodes dépressifs uni ou bipolaires de 51 % au cours de la première année suivant l’arrêt des ECT, et de 37 % à 6 mois, malgré un relais médicamenteux bien conduit (Jelovac, 2013). La place des ECT de continuation, puis de maintenance apparaît à ce jour incontournable dans la stratégie de prévention de la rechute après la phase curative. L’essai contrôlé randomisé de Nordenskjöld (2013) met effectivement en évidence un taux de rechute à 1 an plus faible chez les patients traités par l’association ECT et psychotropes (32 %) comparativement aux patients traités exclusivement par pharmacothérapie (61 %). La question inhérente à la pratique des ECT de continuation puis de maintenance reste leur tolérance clinique. Les principaux effets indésirables redoutés par les praticiens sont les altérations mnésiques. L’étude rétrospective de Elias (2014) n’a pas montré de différence significative sur le plan cognitif avant et après le début des ECT de maintenance sur une période de 12 ans. Cependant, l’apparition d’altérations mnésiques invalidantes chez un patient traité par ECT rend difficile la poursuite de cette thérapeutique. Dans ce contexte, les autres techniques de stimulations transcrâniennes comme la rTms apparaissent comme une alternative thérapeutique.
Nutrient requirements in cattle are dependent on physiological stage, breed and environmental conditions. In Holstein × Gyr crossbred dairy heifers, the lack of data remains a limiting factor for estimating energy and protein requirements. Thus, we aimed to estimate the energy and protein requirements of Holstein × Gyr crossbred heifers raised under tropical conditions. Twenty-two crossbred (½ Holstein × ½ Gyr) heifers with an average initial BW of 102.2 ± 3.4 kg and 3 to 4 months of age were used. To estimate requirements, the comparative slaughter technique was used: four animals were assigned to the reference group, slaughtered at the beginning of the experiment to estimate the initial empty BW (EBW) and composition of the animals that remained in the experiment. The remaining animals were randomized into three treatments based on targeted rates of BW gain: high (1.0 kg/day), low (0.5 kg/day) and close to maintenance (0.1 kg/day). At the end of the experiment, all animals were slaughtered to determine EBW, empty body gain (EBG) and body energy and protein contents. The linear regression parameters were estimated using PROC MIXED of SAS (version 9.4). Estimates of the parameters of non-linear regressions were adjusted through PROC NLIN of SAS using the Gauss–Newton method for parameter fit. The net requirements of energy for maintenance (NEm) and metabolizable energy for maintenance (MEm) were 0.303 and 0.469 MJ/EBW0.75 per day, respectively. The efficiency of use of MEm was 64.5%. The estimated equation to predict the net energy requirement for gain (NEg) was: NEg (MJ/day) = 0.299 × EBW0.75 × EBG0.601. The efficiency of use of ME for gain (kg) was 30.7%. The requirement of metabolizable protein for maintenance was 3.52 g/EBW0.75 per day. The equation to predict net protein requirement for gain (NPg) was: NPg (g/day) = 243.65 × EBW−0.091 × EBG. The efficiency of use of metabolizable protein for gain (k) was 50.8%. We observed noteworthy differences when comparing to ME and protein requirements of Holstein × Gyr crossbred heifers with other systems. In addition, we also observed differences in estimates for NEm, NEg, NPg, kg and k. Therefore, we propose that the equations generated in the present study should be used to estimate energy and protein requirements for Holstein × Gyr crossbred dairy heifers raised in tropical conditions in the post-weaning phase up to 185 kg of BW.
We examined the long-term maintenance of treatment outcomes in patients with acquired brain injuries who participated in community-based neuropsychological rehabilitation (NR) programs, in a prospective, within-subject, longitudinal, partial double-blind cohort study.
One hundred forty-three patients (39 females, mean age 33.5 years) who had experienced a brain injury (BI) (mean time since injury 3.95 years) were referred to a postacute community-based NR institute. Patients participated in one of the three programs aimed at improving their functional outcome: comprehensive–holistic neuropsychological rehabilitation, vocational-focused neuropsychological rehabilitation, and individual neuropsychological rehabilitation. Self-reported data regarding employment, community integration, perceived quality of life (PQoL), and mood were collected at program start and end, and annually for 3 years post program completion. Group placement was based on clinical considerations, such that the study did not aim to compare the programs, but rather to assess their long-term benefits.
Employment status and stability, community integration, and PQoL improved significantly after program completion and continued to improve for the following 3 years. The proportion of individuals with mood disturbances did not change during or after the programs.
A clear consensus regarding BI rehabilitation is that long-term maintenance of treatment outcomes is imperative to its efficacy. Our findings suggest that postacute NR programs provide participants with various tools, skills, and psychological perspectives that they continue to gain from and generalize to real life after program completion, reflecting transformational processes with stable long-term benefits.
Relationships are embedded in broader social networks, including the family and friends of both partners. Covering contributions from several disciplines, this chapter discusses the role of social networks in the maintenance of intimate relationships. We first describe findings from the communication field showing how people use their social networks (such as through doing activities with mutual friends) as one of several strategies to maintain their relationships. Then, we discuss social psychological literature regarding how social networks affect both dyad members’ motivation to engage in various maintenance mechanisms that follow from their decision to commit. Furthermore, the social network can be instrumental in influencing pair members’ ability to maintain their relationship, including by giving advice to help repair relationships, which is also discussed in this chapter. We then turn to more macro-level issues regarding the compositional or structural dimensions of social networks and the ways in which they play a role in the maintenance of couples’ relationships. Variation in the processes of network influence on the maintenance of relationships is also considered, including how networks differentially influence relationship maintenance across the life course and through technology (e.g., social media).
The chapter considers the impact on family law of adopting the concept of the relational self. In particular, it explores the role of family law, the definition of families, financial orders on separation, the definition of parenthood, the concept of parental responsibility and the nature of children's welfare. It explores how a relational self model would ensure that family law protected and promoted valuable relationships.
Recent studies reveal that life in the terrestrial and marine subsurface exists on far less energy flux than is commonly understood from laboratory incubations with isolated organisms. This has profound implications for understanding the development of life on Earth, as well as for the search for life in the universe. Similarly, several recent research efforts have also addressed other limits to life, such as high temperature. This chapter presents an overview of the current understanding of the energetic limits of life on Earth.
The objective lens is regarded as the critical component for an optimal image in light microscopy. Not every damage to the lens surface may be easily visible during maintenance when the objective is removed and observed. The internal lens organization produces a magnified image of the outer lens surface. Shining the light of a laser pointer into the lens, and reproducing the image of the light exiting onto a flat surface, produces different images for intact and damaged objective lenses.
In vitro maintenance of helminth parasites enables a variety of molecular, pharmaceutical and immunological analyses. Currently, the nutritional and environmental in vitro requirements of the equine ascarid parasite, Parascaris spp., have not been determined. Additionally, an objective method for assessing viability of Parascaris spp. intestinal stages does not exist. The purpose of this study was to ascertain the in vitro requirements of intestinal stages of Parascaris spp., and to develop a viability assessment method. A total of 1045 worms were maintained in a total of 212 cultures. Worms obtained from naturally infected foals at necropsy were immediately placed in culture flasks containing 200 mL of culture media. A variety of media types, nutrient supplementation and environmental conditions were examined. A motility-based scoring system was used to assess worm viability. Worms maintained in Roswell Park Memorial Institute-1640 had significantly better viability than any other media (P < 0.0001) and all media types supplemented with any of the nutrients examined (P < 0.0001). The use of a platform rocker also significantly improved viability (P = 0.0305). This is the first study to examine the requirements for maintaining Parascaris spp. intestinal stages in vitro and to evaluate their viability based on movement using an objective scoring system.
The availability of resources including energy, nutrients and (developmental) time has a crucial impact on productivity of farm animals. Availability of energy and nutrients depends on voluntary feed intake and intestinal digestive and absorptive capacity at optimal feeding conditions. Availability of time is provided by the management in animal production. According to the resource allocation theory, resources have to be allocated between maintenance, ontogenic growth, production and reproduction during lifetime. Priorities for these processes are mainly determined by the genetic background, the rearing system and the feeding regimen. Aim of this review was to re-discuss the impact of a proper resource allocation for a long and healthy life span in farm animals. Using the barrel model of resource allocation, resource fluxes were explained and were implemented to specific productive life conditions of different farm animal species, dairy cows, sows and poultry. Hypothetically, resource allocation mismatch neglecting maintenance is a central process, which might be associated with morphological constraints of extracellular matrix components; evidence for that was found in the literature. A potential consequence of this limitation is a phenomenon called disproportionate growth, which counteracts the genetically determined scaling rules for body and organ proportions and could have a strong impact on farm animal health and production.
Most mid-life and older adults are not achieving recommended physical activity (PA) targets and effective interventions are needed to increase and maintain PA long-term for health benefits. The Pedometer And Consultation Evaluation (PACE-UP) trial, a three-armed primary care pedometer-based walking intervention in those aged 45–75 years, demonstrated increased PA levels at 12 months. A three-year follow-up was conducted to evaluate long-term PA maintenance, including a qualitative component.
To examine facilitators and barriers to PA maintenance in mid-life and older adults previously involved in a PA trial.
Semi-structured telephone interviews were conducted with 60 PACE-UP participants across all study arms. Interviews were audio-recorded, transcribed verbatim and coded independently by researchers, prior to thematic analysis.
Two-thirds of participants felt since the PACE-UP trial they had an awareness of PA, with the pedometer reported as ‘kick-starting’ regular activity, and then helped them to maintain regular activity. PA facilitators included: maintaining good health, self-motivation, social support and good weather. Lack of time was the most frequently cited barrier. Other barriers were often the inverse of the facilitators; for example, poor health and bad weather. Participants described the type of ‘top-up’ intervention they would find beneficial to aid PA maintenance (eg, text messages, online resources and walking groups).
A challenge for future PA interventions is to transform barriers into facilitators; for example, educating trial participants about the value of PA for many chronic health conditions to change this from inhibiting to promoting PA. Participants provided ideas for encouraging PA maintenance which could be incorporated into future interventions.
An experiment was carried to evaluate the energy and protein requirements for the growth and maintenance of lambs of different sex classes. In all, 38 hair lambs (13.0±1.49 kg initial BW and 2 months old) were allocated in a factorial design with diet restriction levels (ad libitum, 30% and 60% feed restriction) and sex classes (castrated and non-castrated males). Four animals from each sex class were slaughtered at the beginning of the trial as a reference group to estimate the initial empty BW and body composition. The remaining lambs were weighed weekly to calculate BW gain (BWG), and when the animals fed ad libitum reached an average BW of 30 kg, all of the experimental animals were slaughtered. Before slaughter, fasted BW (FBW) was determined after 18 h without feed and water. Feed restriction induced reductions in body fat and energy concentration, whereas water restriction showed the opposite effect, and the protein concentration was not affected. The increase in BW promoted increases in body fat and energy content, and these increases were greater in castrated lambs, whereas the protein content was similar between classes tending to stabilize. The net energy required for gain (NEg) and the net protein required for gain (NPg) were not affected by sex class; therefore, an equation was generated for the combined results of both castrated and non-castrated lambs. The NEg varied from 1.13 to 2.01 MJ/day for lambs with BW of 15 and 30 kg and BWG of 200 g. The NPg varied from 24.57 to 16.33 g/day for lambs with BW of 15 and 30 kg and BWG of 200 g. The metabolizable energy efficiency for gain (kg) was 0.37, and the metabolizable protein efficiency for gain (kpg) was 0.28. The net energy required for maintenance (NEm) and the net requirement of protein for maintenance (NPm) did not differ between castrated and non-castrated lambs, with values of 0.241 MJ/kg FBW0.75 per day and 1.30 g/kg FBW0.75 per day, respectively. The metabolizable energy efficiency for maintenance (km) was 0.60, and the efficiency of metabolizable protein use for maintenance (kpm) was 0.57. Nutritional requirements for growth and maintenance did not differ between castrated and non-castrated lambs. This study emphasizes the importance of updating the tables of international committees and of including data obtained from studies with sheep breeds raised in tropical conditions, with the purpose of improving the productive efficiency of the animals
Although classical randomized clinical trials (RCTs) are the gold standard for proof of drug efficacy, randomized discontinuation trials (RDTs), sometimes called “enriched” trials, are used increasingly, especially in psychiatric maintenance studies.
A narrative review of two decades of experience with RDTs.
RDTs in psychiatric maintenance trials tend to use a dependent variable as a predictor: treatment response. Treatment responders are assessed for treatment response. This tautology in the logic of RDTs renders them invalid, since the predictor and the outcome are the same variable. Although RDTs can be designed to avoid this tautologous state of affairs, like using independent predictors of outcomes, such is not the case with psychiatric maintenance studies
Further, purported benefits of RDTs regarding feasibility were found to be questionable. Specifically, RDTs do not enhance statistical power in many settings, and, because of high dropout rates, produce results of questionable validity. Any claimed benefits come with notably reduced generalizability.
RDTs appear to be scientifically invalid as used in psychiatric maintenance designs. Their purported feasibility benefits are not seen in actual trials for psychotropic drugs. There is warrant for changes in federal policy regarding marketing indications for maintenance efficacy using the RDT design.
Review efficacy, safety, and tolerability of brexpiprazole in patients with schizophrenia in short- and long-term phase 3 studies.
Patients experiencing a current exacerbation of schizophrenia received brexpiprazole in two fixed-dose (2 and 4 mg), 6-week, placebo-controlled studies, one flexible-dose (2–4 mg), 6-week, placebo-control and active reference study, and one fixed-dose (1–4 mg), 52-week, placebo-controlled maintenance study.
The efficacy of brexpiprazole was demonstrated in the two short-term fixed-dose studies with statistically significant improvements from baseline in Positive and Negative Syndrome Scale (PANSS) total score compared with placebo. In the flexible-dose short-term study, treatment with brexpiprazole resulted in numerically greater improvements in PANSS total score than with placebo that approached statistical significance (p=0.056). A meta-analysis of these short-term studies showed a mean change in PANSS total score of −20.1, reflecting a clinically meaningful reduction in symptoms. In the maintenance study, brexpiprazole had a beneficial effect relative to placebo on time to exacerbation of psychotic symptoms/impending relapse (p<0.0001). For all studies, brexpiprazole demonstrated clinically meaningful treatment effects on the Personal and Social Performance scale. Brexpiprazole had a favourable safety profile, with a relatively low prevalence of activating and sedating side effects. Weight gain in the short-term studies was ~1 kg greater than placebo. No safety concerns were observed with brexpiprazole in laboratory values, electrocardiogram, or vital signs.
Overall, the results indicate brexpiprazole, used either short-term or as part of a long-term maintenance treatment programme, is an efficacious therapy option in adults with schizophrenia and has a favourable safety/tolerability profile.